Source: http://www.awkolaw.com/drugs.html

March, 2010

Before a newly developed drug can be sold commercially, it must first endure an

exhaustive clinical trial process through which it is tested for safety, toxicity, side effects

and efficacy. The final phase of any drug clinical trial revolves around Food and Drug

Administration (FDA) approval, clearing it for distribution.

FDA approval does not void a drug manufacturer's liability for defects or severe side

effects that are caused as a result of using their drugs. Drug manufacturers are required to take comprehensive measures to ensure that their products are safe. Failure to disclose any side effects, defects, or other such complications associated with their drugs is negligent and grounds for legal action.

The purpose of the clinical trial process is to test the drug across a wide variety of populations so as to monitor sporadic issues affecting specific groups (gender, age, race, etc.)

Although the final phase of any drug clinical trial revolves around long-term studies

designed to monitor the effects of continued use of the drug, latent effects can present

themselves after FDA approval of the drug and after it has been widely distributed and

used.

ACCUTANE

Roche Accepts No Responsibility in Withdrawal of Accutane

Thursday, July 23rd, 2009

June 26, 2008

The manufacturer of Accutane, Roche Holding AG, has withdrawn its acne drug Accutane from the U.S. market after several trials during which juries awarded damages of more than $33 million dollars in compensation to injured consumers who alleged that their use caused them to suffer bowel disease including ulcerative colitis, a form of inflammatory bowel disease (IBD).

Accutane had been manufactuered, supplied, marketed and sold to approximately 13

million consumers since it was introduced to the market in 1982. The medication was

Roche’s second-biggest selling drug but its sales fell precipitously after it lost its long

standing sole patent to generic manufacturers.

Roche communicated its decision to withdraw Accutane from the U.S. market to the Food and Drug Administration. Its spokes person issued a statement in which it failed to accept accountability, saying only:

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the

company continues to defend vigorously.”

Accutane Recall – Accutane Taken Off Market – Accutane Side Effects

Monday, June 29th, 2009

Roche Holding AG Recalls Accutane Following Lawsuit Verdict

Hoffman-LaRoche, the largest manufacturer of cancer medications, issued a recall for

Accutane, an oral medication intended to treat severe acne. Accutane has been widely

linked to several adverse side effects since its release in 1984, including psychological

changes, suicidal behavior, auto-immune disease, central nervous system problems and birth defects.

In June 2009, Roche announced a recall of the medication after a court decision awarded more than $33 million in damages to victims of Accutane injury. Prior to the June 2009 court order, Roche was required to pay damages in several other cases, including $13 million in November 2008, $10.5 million in April 2007, $2.62 million in May 2007 and $7 million in October 2007.

Facing 5,000 more product liability claims, Roche cited the high cost of lawsuits as one of its main factors in pulling the product. In addition to discontinuing the product in the United States, Roche has also pulled Accutane from 11 other international markets. Patients are still able to obtain Accutane from pharmacies, but not directly from Roche.

Accutane Side Effects – Accutane Suicide and Bowel Diseases

Accutane has been linked with a wide range of life-threatening side effects, including

psychiatric problems. More than 142 suicide cases involving Accutane have been reported to the Food and Drug Administration (FDA). In response, the FDA issued a warning to healthcare professionals to monitor their patients for signs of depression while they are on the medication.

Additionally, several patients claim Accutane caused side effects including musculoskeletal disorders, multiple sclerosis, diabetes, hepatitis, hepatotoxicity, liver damage, kidney damage, lupus, birth defects and fetal death.

Recently, the acne medication has been linked to gastrointestinal disorders, including:

• Crohn’s disease

• Inflammatory bowel disease (IBD)

• Irritable bowel syndrome (IBS)

• Ulcerative colitis

More than 13 million people in the United States use Accutane, which was once Roche’s second-best selling drug.

ADHD MEDICATION

ADHD Medication - Side Effects May Cause Death in Children

The Food and Drug Administration (FDA) is evaluating the potential life-threatening side

effects of stimulant medications, including Ritalin and Adderall. Some stimulant

medications are used to treat attention-deficit/hyperactivity disorder (ADHD), a condition

diagnosed in four to eight percent of children.

The continued FDA evaluation follows a study suggesting children who take stimulant

medications are at risk for sudden cardiac death and other cardiovascular complications.

ADHD Medication Side Effects

In June 2009, the American Journal of Psychiatry published a study comparing 564

children who died in automobile accidents with 564 children who died unexpectedly of

unknown causes – later attributed to cardiac arrhythmias. Approximately two percent of

those who died from undiagnosed cardiac arrhythmias were taking stimulant medications.

While the study does not prove a causal relationship between stimulant medications and sudden cardiac death, many believe it highlights the potential risk of prescribing ADHD medications and other stimulants to children without screening for heart conditions.

Although the previous study has several limitations, the FDA and the Agency for

Healthcare Research are performing an additional study to further determine any link

between ADHD medications and sudden cardiac death.

Child Safety and Ritalin and Adderall

Ritalin and Adderall are two of the most abused prescription medications available on the market. Many parents worry that their children will continue their use of stimulant

medications, despite successfully managing the symptoms of ADHD without medication.

Others are concerned about the potential of serious side effects, including personality

changes, uncontrolled movements, verbal tics, changes in heartbeat and mood swings.

The FDA has advised parents to continue their normal administration of ADHD

medications until further research has been conducted.

ADVAIR

Advair Inhalers Given “Black Box” Warning by FDA

In 2003, the Food and Drug Administration (FDA) issued a black box warning, its sternest notice, to any medication that contains salmeterol, including Advair. Salmeterol is a long acting beta-2 agonist (LABA) that has been linked to 13 deaths in clinical trials, as well as an increase in the severity of asthma attacks.

Advair is a prescription inhaler that is intended to treat asthma and chronic obstructive

pulmonary disease (COPD). Manufactured by GlaxoSmithKline, Advair is prescribed to

more than 17 million people in the United States. Although Advair has yet to be recalled

from the market, patients who have experienced harm as a result of Advair use might be eligible to file a claim against the drug manufacturer.

Advair Side Effects – Advair Deaths

Many patients who have taken Advair developed a number of adverse reactions because of the medication. Some common Advair side effects are:

• Bronchial inflammation and sensitivity

• Ear, nose and throat irritation

• Headache

• Hives

• Muscle aches

• Rash

• Respiratory symptoms

• Skin irritation

• Swelling

In addition to worsening the symptoms of respiratory disease, Advair increases the rate of death in patients suffering from asthma. More than 13 deaths from severe asthma attacks caused by salmeterol-based drugs have been reported to the FDA.

ALLI

Xenical, Alli (Orlistat) Side Effects Linked to Liver Failure

In August 2009, the Food and Drug Administration (FDA) announced it was investigating reports of liver injury and liver failure associated with the weight loss drug, orlistat. The FDA received 32 reports of liver problems in orlistat users, including 27 reports of hospitalization and six reports of liver failure.

Orlistat is marketed by Roche Pharmaceuticals under the name Xenical, and by

GlaxoSmithKline under the name Alli — the first and only FDA-approved, non-prescription weight loss drug.

Alli and Xenical Side Effects Include Liver Damage

The prescription brand of orlistat, Xenical, and its over-the-counter counterpart, Alli, work by blocking the absorption of fat in the digestive tract to help patients absorb fewer

calories, and subsequently lose weight.

Xenical prescriptions can only be obtained through a physician who has determined that

patients meet the criteria to be considered clinically obese, including a body mass index

that exceeds 30. Alli can be purchased at any retail store and boasts more than four million users worldwide, serving as a billion-dollar product for GlaxoSmithKline.

From 1999 to 2008, the FDA has received 32 reports of liver damage with the most

common symptoms including jaundice, stomach pain and weakness. The FDA is

investigating the link between orlistat and liver damage; however, it states that "no definite association between liver injury and orlistat has been established at his time."

Physicians and consumers are urged to maintain regular use of the product unless they

demonstrate symptoms of liver damage.

Patients taking Alli or Xenical should monitor their health for the following liver damage

side effects, including:

• Abdominal pain

• Brown urine

• Fatigue

• Light-colored stool

• Loss of Appetite

• Nausea

• Vomiting

• Yellowing of the eyes and skin (jaundice)

AMIODARONE

Amiodarone Linked with Serious Side Effect in Women

The heart drug amiodarone has been linked with causing a serious side effect in female

patients. Amiodarone is used as a treatment for atrial fibrillation, a heartbeat abnormality causing rapid vibrations in the upper chambers of the heart.

Marketed under the brand name of Cordarone, amiodarone was approved for use by the Food and Drug Administration in 1985. Although amiodarone was developed in the 1960s, the FDA was reluctant to approve the drug earlier because of reports linking it with serious pulmonary side effects.

Amiodarone and Women

Women taking amiodarone are at increased risk of developing a side effect requiring the

need for a pacemaker. Although amiodarone is designed to regulate heart rhythm, it may exacerbate the problem in women, requiring the surgical implantation of an invasive cardiac device that regulates the heartbeat.

Although amiodarone is used by both men and women suffering from arrhythmia, its

serious side effect only appears to affect women. Women taking amiodarone should

consult with their physician to determine whether or not they should begin an alternate

treatment.

ARANESP

FDA Investigates Epogen, Aranesp & Procrit Anemia Drugs Side Effects

The Food and Drug Administration (FDA) is set to form an independent panel of experts to re-evaluate the safety of three major anemia drugs, Epogen, Aranesp and Procrit. Agency officials say they expect to release new dosage and warning labels over the next several months.

The FDA decision comes one month after a recent study raised major safety concerns,

indicating that the anemia drugs — sold by Amgen and Johnson & Johnson — may double the risk of stroke and heart attack at current dosage levels.

Epogen, Aranesp and Procrit Side Effects

Epogen, Aranesp and Procrit are frequently prescribed to patients suffering from diabetes and chronic kidney disease. The popular anemia drugs also are commonly prescribed to cancer patients following chemotherapy treatments. In addition, the study indicates that the drugs may worsen the survival rate of certain cancer patients.

The FDA panel is set to re-evaluate whether patients should be given lower doses of

anemia drugs and how this may help decrease current health risks associated with

Epogen, Aranesp and Procrit.

In the meantime, the sales of anemia drugs continue to decline, while Amgen claims the

clinical trials are based on lack of understanding on how anemia drugs work. In addition,

both drug companies have admitted paying millions of dollars to doctors in return for

prescribing their patients anemia medicine. The total amount of payments has yet to be

disclosed by Amgen and Johnson & Johnson, as the FDA prepares to further investigate the safety of all three drugs. Anemia drug users are advised to discuss their options with their physician to determine the best course of action.

ASTHMA INHALERS

FDA Issues New Usage Recommendations for LABA Asthma Inhalers – Advair Side Effects

The FDA has released documents announcing label changes, recommended usage

guidelines and other initiatives intended to promote safe use of popular asthma drugs

containing Long-Acting Beta-Agonists, (LABAs).

Package inserts for the two single-agent LABAs approved for asthma — single-ingredient products Serevent and Foradil, as well as combination medications Advair and Symbicort — will be changed to require that the drugs are always used in combination with an asthma controller medication such as an inhaled corticosteroid.

Side Effects of Advair, Serevent, Etc. - Recommended Usage for LABAs

FDA action comes after a careful examination of recent studies suggesting that treating

asthma and breathing problems with LABAs alone may lead to serious side effects,

including:

• Worsening of asthma symptoms

• Heart attack

• Death

The FDA recommends the following:

• LABAs should not be used for long-term treatment of asthma

• LABAs always should be used in combination with other inhaled medications

How LABAs Work

LABAs like Advair, Serevent, Symbicort and Foradil are generally taken through an inhaler to relax the muscles of the airways, allowing unrestricted airflow to the lungs. LABA effects last for 12 hours and do not treat the sudden-onset of an asthma attack.

LABAs also may be used to relieve symptoms of a lung condition known as chronic

obstructive pulmonary disease and exercise-induced bronchospasm.

Other LABAs Initiatives

In addition to the new labels, the FDA has asked the manufacturers of LABAs to begin a

risk management program called Risk Evaluation and Mitigation Strategy to inform both

patients and physicians of the new findings and possible health risks associated with

popular LABAs like Advair.

The FDA also is demanding further clinical trials that will be conducted by the

manufacturers of LABAs in order to continue studying the side effects. However, the FDA says it believes that the drug's benefits still outweigh the risks, which is why it is ordering a recall of the drugs.

AVANDIA

What is Avandia? What are its Side Effects?

Avandia is a drug developed by GlaxoSmithKline for people suffering from type 2 diabetes mellitus. Type 2 diabetes is also referred to as “adult-onset” diabetes and “non-insulin dependent” diabetes. It is caused when a person’s body does not make enough insulin, or when their body cannot respond appropriately to its insulin production.

Avandia treatment is intended to lower blood sugar when used in conjunction with an

appropriate diet and exercise. Avandia can also be used in association with other diabetes drugs to best target the condition and its effects. Avandia is taken in tablet form in a starting dose of 4mg (once a day) or 2mg (twice a day).

While it has been found to aid in the treatment of type 2 diabetes, it has been associated with certain side effects, notably the issue of increased incidence of bone fracture in female patients.

Although Avandia has proven to be an effective mode of treatment of people suffering from type 2 diabetes mellitus, it has also been linked with the development of some serious side effects.

Recent studies have linked Avandia with serious cardiovascular problems including heart attack and cardiovascular death. In fact, the latest study published in the American Diabetes Association medical journal concludes that side effects of Avandia may double the risk of heart attack when compared to other types of diabetes drugs.

Patients taking Avandia may also be at risk of developing a cardiovascular disease called primary pulmonary hypertension (PPH). While PPH is most commonly associated with a higher-than normal blood pressure in the pulmonary artery, it has also been shown to be associated with the development of heart valve disease and/or heart valve defects.

Avandia patients who develop PPH may be entitled to receive compensation.

Avandia Black Box Warning

The controversy surrounding popular diabetes drug Avandia continues to grow as new

information comes out regarding GlaxoSmithKline’s knowledge of Avandia heart risk.

A June 6, 2007 congressional hearing in Washington yielded damning information from a medical expert who testified that he approached the pharmaceutical company in 1999 with information related to Avandia heart risk. His testimony detailed legal threats issued by GlaxoSmithKline executives (then SmithKline Beecham) if he were to make noise

regarding the serious cardiovascular side effects associated with the diabetes drug. On

June 7, 2007, the Food and Drug Administration took action against GlaxoSmithKline by

requiring a “black box” warning for Avandia that would alert consumers to the

cardiovascular risk. “Black box” warnings are the most serious required by the FDA, and

one-step closer to recall.

In addition to Avandia, the FDA will also require that Takeda Pharmaceuticals’ Actos

include the same “black box” warning.

Avandia Update

On November 14th, 2007, the FDA added a second Black Box warning to Avandia for

heart attack risks - The New England Journal of Medicine published a study in May of

2007 that found a 43 percent increase in heart attacks for Avandia users. A panel voted to allow the diabetes drug to remain on the market, though the FDA has directed

GlaxoSmithKline to initiate a new study to determine long-term cardiovascular risks.

The FDA’s most recent Black Box warning follows the analysis of 42 clinical studies evaluating the efficacy of Avandia. The studies involved more than 14,000 patients and found a link between the use of Avandia and an increased risk of heart attack.

BYETTA

Byetta Diabetes Drug Linked with Fatal Pancreatitis

The Food and Drug Administration (FDA) is alerting Byetta users to serious risks

associated with use of the under-fire diabetes drug. Federal regulators are seeking

implementation of stronger labels for Byetta, which may mean issuing a black box warning, the most serious warning label required by the FDA.

Byetta, the brand name for exenatide, is a twice-daily diabetes drug developed and

marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co for the treatment of type 2

diabetes. Gaining FDA approval in 2005, Byetta is designed to lower the blood glucose

levels of diabetes patients.

Byetta is one of Amylin Pharmaceuticals’ best selling drugs, with worldwide sales of

exceeding $650 Million in 2007.

Byetta and Pancreatitis

Use of Byetta has been linked with increased risk of hemorrhagic or necrotizing

pancreatitis. In October 2007, a total of 30 cases of Byetta-related pancreatitis were

reported to the FDA. Although these cases did not result in any deaths, Amylin

Pharmaceuticals issued an alert to doctors and patients, and updated their labels to

include additional information related to Byetta pancreatitis risks.

On August 18th, 2008, The FDA received six new reports of Byetta-related pancreatitis.

Unlike the 30 cases reported in 2007, there were two deaths associated with the 2008

incidents. The manufacturers of Byetta were quick to respond to the FDA report by

acknowledging the increased, albeit rare, potential for pancreatitis associated with the use of the diabetes drug. However, Amylin and Eli Lilly were quick to point out that people suffering from diabetes are already at increased risk of suffering pancreatitis.

With more than 700,000 diabetes sufferers using Byetta worldwide, FDA officials are

hoping to spread the word about the potentially fatal Byetta side effect before any more

people are hurt. Patients using Byetta are advised to consult with their doctor immediately and cease use of the drug if signs of acute pancreatitis are exhibited.

These signs can include (but are not limited to):

• Nausea

• Vomiting

• Abdominal / back pain

• Fever

• Bruising of the lower back and/or navel

• Abnormally foul smelling, pale, oily feces

CIPRO

Cipro Side Effect Prompts Black Box Warning

Two leading brands of potent antibacterial drugs have come under increased scrutiny by the Food and Drug Administration following reports of serious injury linked with their use.

Cipro and Levaquin - manufactured by Bayer and Ortho-McNeil respectively - are part of a class of antibacterial drugs known as flouroquinolones. Although the FDA warning is directed towards all drugs from the flouroquinolone family, Cipro and Levaquin have been directly targeted due to their popularity.

Cipro Black Box Warning

In an effort to alert consumers and doctors about the potential side effects associated with the use of Cipro and other flouroquinolones, the FDA has issued a black box warning. Black box warnings are the most urgent and severe safety warnings imposed by the FDA and are designed to serve as a highly noticeable alert for drug users.

The FDA issued the black box warning following intense pressure from the consumer

advocacy group Public Citizen. The organization petitioned the FDA for nearly two years

following reports of tendon rupture risks associated with the use of Cipro, Levaquin and

other flouroquinolones. Public Citizen believes that the FDA acted late in issuing a black

box warning, putting countless numbers of flouroquinolone users at risk of injury.

Although acquiescing to Public Citizen’s efforts, the FDA pointed out that the drug labels

already warned of a potential tendon injury risk associated with use of the drug. The black box warning was issued in conjunction with the development of new literature emphasizing the tendon injury risk as a measure intended to fully underscore this warning.

Cipro Tendon Rupture Risks

Cipro and other flouroquinolones have been linked with tendon rupture injuries. Tendon

injuries typically result from over-activity or trauma. Experts studying the link between

flouroquinolones and tendon rupture are unclear as to the exact nature of the side effect, though research is ongoing.

The FDA has not released a specific number of people injured through flouroquinolone

use; however, Public Citizen has reported the number exceeded 400 people in 2007 alone.

The most common tendon linked with flouroquinolone-based rupture is the Achilles tendon. Reports indicate that the injury often occurred without previous pain or warning, suggesting a potential toxicity issue faced by certain individuals. Typically, flouroquinolone injury victims reported pain and swelling prior to rupture, leading experts to believe that injury could be avoided in such instances by halting use of the drug.

Flouroquinolone users facing an increased risk of tendon rupture include:

• People aged 60 and over.

• People taking steroids.

• Heart, lung or kidney transplant recipients.

COX-2

COX-2 Inhibitor

A COX-2 inhibitor is a type of non-steroidal anti-inflammatory drug (NSAID) that is used to reduce pain, fever and inflammation. NSAIDs block the body's natural defense mechanism against injury by inhibiting the release of prostaglandins (hormone-like chemical messengers). Aspirin and ibuprofen are two of the more common NSAIDs.

COX-2 inhibitors target the COX-2 enzyme, a naturally occurring cyclooxygenase (COX) enzyme that is responsible for causing inflammation and pain. The COX-2 enzyme is one of two naturally occurring cyclooxygenase enzymes; the COX-1 enzyme being the other.

COX-1 and COX-2 enzymes produce prostaglandins and therefore play a role in the

promotion of pain, fever and inflammation associated with the body's defense against

injury. The primary difference between COX-1 and COX-2 enzymes is that COX-1

enzymes protect the stomach lining from certain digestive acids while also helping to

maintain kidney functionality.

As opposed to COX-2 inhibitors, traditional NSAIDs inhibit both COX-1 and COX-2

enzymes. By inhibiting COX-1 enzymes, traditional NSAIDs limit the production of "good

prostaglandins" serving as protection of the stomach lining. COX-2 inhibitors only target

COX-2 enzymes, sparing patients from the intestinal irritation that is commonly associated with NSAID usage.

COX-2 Inhibitors Side Effects

The use of COX-2 inhibitors has been linked with the possible development of a variety of mild to severe side effects. The most serious of these side effects, which are now known to occur with some frequency, are cardiovascular side effects and Stevens Johnson Syndrome, a serious allergic skin reaction. These side effects depend on the patient and his or her dosage. The cardiovascular side effects include myocardial infarction (heart attack), thrombosis (blood clots) and stroke. These serious cardiovascular conditions, along with the occurrence of Stevens Johnson Syndrome, have lead to close scrutiny of all COX-2 inhibitors and the recall of two of them.

There are a number of notorious COX-2 inhibitors that have garnered a great deal of

attention because of their propensity to cause the development of serious side effects in

patients being treated with the various drug types.

Notorious COX-2 Inhibitors

The three most notorious COX-2 inhibitors are Vioxx, Celebrex and Bextra.

Vioxx - Vioxx is the brand name for rofecoxib, arguably the most notorious of the COX-2

inhibitors. Developed and marketed by Merck & Co., Vioxx was voluntarily withdrawn from the market on September 27th, 2004, after a slew of medical reports linked the COX-2 inhibitor to patients' increased risk of heart attack and stroke. Merck & Co. has found itself at the center of personal injury litigation focused on compensating the many victims of the controversial COX-2 inhibitor.

Celebrex - Celebrex is the brand name for celecoxib, a type of COX-2 inhibitor that is

commonly associated with the treatment of osteoarthritis and rheumatoid arthritis.

Developed and marketed by Pfizer, Celebrex received Food and Drug Administration

(FDA) approval in 1998 and has been prescribed to more than 29 million people.

Although Celebrex has not yet been recalled, it faces increased scrutiny because of its relation to Vioxx and its potentially harmful side effects such as Stevens Johnson Syndrome, heart attack or stroke. In addition to the potential cardiovascular side effects, Celebrex is also linked to Stevens Johnson Syndrome.

Bextra - Bextra is the brand name for valdecoxib, a prescription drug that, like Celebrex, is used for the treatment of osteoarthritis and rheumatoid arthritis. Developed and marketed by G.D. Searle and Company, Bextra was removed from market on April 7th, 2005, because of concerns regarding side effects associated with use of the drug.

Although Bextra has not been associated with the serious cardiovascular side effects to the same extent as Vioxx, the occurrence of Stevens Johnson Syndrome is much more common with Bextra use than with other COX-2 inhibitors.

Vioxx, Celebrex and Bextra are three COX-2 inhibitors that have found themselves at the center of personal injury litigation because of the serious side effects that have resulted from use of the drugs. Those who have been injured may be eligible for compensation.

The law offices of Aylstock, Witkin, Kreis & Overholtz boast some of the most experienced personal injury lawyers Pensacola, Florida has to offer. Contact them today to get information about victims of COX-2 inhibitor side effects rights to compensation.

DESMOPRESSIN

FDA Warns of Desmopressin Acetate Side Effects

The Food and Drug Administration has asked for a label update for all formulations of

desmopressin acetate. This includes the intranasal formulation and tablet form of the drug, both of which have been linked with serious side effects.

Desmopressin acetate was developed to mimic vasopressin, a type of naturally-occurring antidiuretic hormone that inhibits the immoderate loss of water through urine. Synthetic vasopressin in the form of desmopressin acetate has often been prescribed as a solution to primary nocturnal enuresis (PNE), a bed-wetting disorder. However, recent studies have linked desmopressin - specifically the intranasal formulation - with serious and potentially life threatening side effects.

Desmopressin Side Effects and the FDA

Desmopressin has been linked with the potential development of severe hyponatremia and seizures. Hyponatremia is a condition in which the sufferer experiences abnormally low levels of sodium in their blood. Moderately low levels of sodium in the blood can cause cellular malfunction, and exorbitantly low levels can lead to death. Children are at an increased risk of developing desmopressin side effects.

An FDA study evaluated 61 seizure cases related to hyponatremia (two of which resulted in death). Of the 61 cases, 36 were linked with the intranasal formulation. Of these 36, 25 were children. Based on the results of the study, the FDA has suggested that intranasal desmopressin no longer be used for the treatment of PNE, and has requested that all desmopressin formulations include a warning alerting consumers to the hyponatremia and seizure risk associated with use of the drug.

Desmopressin formulations are marketed in a variety of ways, including:

• DDAVP Nasal Spray

• DDAVP Rhinal Tube

• DDAVP

• DDVP

• Minirin

• Stimate Nasal Spray

Patients currently taking any of the aforementioned desmopressin formulations are

advised to consult with their physician to determine an appropriate course of action.

DIGITEK

Recalled Digitek Pills Linked with Severe Adverse Reactions

The Food and Drug Administration (FDA) issued a class I recall - the most severe FDA

recall - in April 2008 for under-fire heart drug Digitek. The recall follows reports of severe adverse reactions linked with over-dosed Digitek pills. The recalled pills are believed to carry twice the recommended strength and run the risk of causing an overdose in the form of digitalis toxicity.

Digitek Pills Marketed Under Bertek and UDL Brand Names

Digitek is the trade name for digoxin or digitalis, a heart drug commonly used in the

treatment of irregular heart rhythms (arrhythmia) or congestive heart failure. Manufactured by Actavis Totowa, Digitek has been marketed by Mylan Pharmaceuticals and UDL Laboratories under the brand names “Bertek” and “UDL.”

As brands of Digitek, Bertek and UDL have been included in the recall. Patients taking

Bertek and UDL should consult with their physician about getting an alternative

medication.

Digitek and Digitalis Toxicity

The Digitek recall was issued in response to reports of digitalis toxicity affecting patients

taking the prescribed dosage of Digitek. The recalled Digitek pills may contain twice the

intended amount of digoxin, yielding the potential for overdose and corresponding adverse effects. Actavis Totowa has claimed that this oversight could have resulted from pills being manufactured with twice the appropriate thickness, yielding a corresponding increase in digoxin levels.

Symptoms of digitalis toxicity may include dizziness, nausea/vomiting, low blood pressure and arrhythmia. One lawsuit filed by a digitalis toxicity victim claimed low heart rate, speech problems, confusion and blindness. The victim also suffered severe heart damage and required the placement of a pacemaker to regulate heartbeat. A number of other federal lawsuits have been filed by Digitek injury victims, including one wrongful death claim in which the victim died as a result of the overdose.

ELIDEL

Elidel and the FDA 'Black Box' Warning

Elidel use has recently been linked with the possible development of lymphoma and/or

skin cancer. While a causative link between Elidel and cancer remains inconclusive at this point, initial data is such that it has led the FDA to issue a new safety warning with regards to use of the immunomodulating agent.

The FDA began to take notice of the possible relationship between skin cancer, lymphoma and Elidel use in 2005. Efforts made by the FDA to institute significant warning label changes were met with resistance by Novartis, the manufacturers of the drug. However, in January of 2006, the FDA required that Elidel be labeled with a "black box" warning advising patients and doctors of the serious nature of Elidel side effects.

About Elidel

Elidel is the brand name for pimecrolimus, a type of prescription-only immunomodulating agent that is most often used as a topical ointment for the treatment of atopic eczema.

Elidel is manufactured and marketed by Novartis, a multinational pharmaceutical company.

The immunosuppressant nature of Elidel can weaken a patient's immune system to such an extent that they become increasingly susceptible to the development of a variety of diseases and cancers.

Elidel is similar in nature to another type of topical immunosuppressant that has recently

come under FDA fire because of its possible link with cancer; Protopic (tacrolimus). Both drugs are used to treat atopic eczema and both have recently been required to include "black box" warnings on their labels to make patients and doctors fully aware of the possible side effects associated with use.

Elidel Use

Elidel is the most common form of treatment for atopic eczema, a type of allergic

inflammation of the skin that causes itching, reddening, scaling and blistering. Elidel is

prescribed for twice-a-day application to control the symptoms of mild-to-moderate

eczema.

Patients are advised to spread a thin layer of Elidel ointment on the affected area two

times a day until symptoms of atopic eczema subside. It can take several weeks of

treatment with Elidel to produce an effect; however, if the symptoms have not cleared after six weeks, treatment should be halted and a medical professional should be consulted.

Elidel should not be used by anyone who is predisposed to the development of skin cancer or lymphoma. Additionally, the topical immunosuppressant should not be used by children under the age of two.

Elidel Side Effects

There are a number of side effects that have been associated with the use of Elidel in the treatment of atopic eczema, some of which include:

• Warm / burning sensation on area of Elidel application

• Cold-like symptoms

o Cough

o Sore throat

o Congestion

• Headache

• Viral skin infection

• Cancer

EPOGEN

FDA Investigates Epogen, Aranesp & Procrit Anemia Drugs Side Effects

The Food and Drug Administration (FDA) is set to form an independent panel of experts to re-evaluate the safety of three major anemia drugs, Epogen, Aranesp and Procrit. Agency officials say they expect to release new dosage and warning labels over the next several months.

The FDA decision comes one month after a recent study raised major safety concerns,

indicating that the anemia drugs — sold by Amgen and Johnson & Johnson — may double the risk of stroke and heart attack at current dosage levels.

Epogen, Aranesp and Procrit Side Effects

Epogen, Aranesp and Procrit are frequently prescribed to patients suffering from diabetes and chronic kidney disease. The popular anemia drugs also are commonly prescribed to cancer patients following chemotherapy treatments. In addition, the study indicates that the drugs may worsen the survival rate of certain cancer patients.

The FDA panel is set to re-evaluate whether patients should be given lower doses of

anemia drugs and how this may help decrease current health risks associated with

Epogen, Aranesp and Procrit.

In the meantime, the sales of anemia drugs continue to decline, while Amgen claims the

clinical trials are based on lack of understanding on how anemia drugs work. In addition,

both drug companies have admitted paying millions of dollars to doctors in return for

prescribing their patients anemia medicine. The total amount of payments has yet to be

disclosed by Amgen and Johnson & Johnson, as the FDA prepares to further investigate the safety of all three drugs.

Anemia drug users are advised to discuss their options with their physician to determine

the best course of action.

EHTEX

Ethex Corporation Issuing Recall For Morphine Tablets and Other Medications

In January 2009, the Food and Drug Administration (FDA) and Ethex Corporation issued a voluntary recall of more than 60 medications deemed unfit for use. The list includes morphine tablets, narcotics, cardiac drugs and prenatal and iron supplements.

The Ethex recall follows reports of faulty manufacturing, which could potentially expose

patients to deadly amounts of medication. In some instances, morphine tablets

administered almost twice the amount of the recommended dosage.

Patients who have taken morphine tablets or other recalled Ethex products are at severe risk for death from overdose, as well as several other adverse side effects, including arrhythmia, low blood pressure and respiratory depression.

If you or someone you know has taken these medications and experience side effects,

please seek immediate medical attention.

Ethex Recall and Morphine Side Effects

Ethex Corp., a subsidiary of KV Pharmaceutical Company, has recalled approximately 60 products from the wholesale and retail levels due to faulty manufacturing that is not in compliance with the current Good Manufacturing Practice (cGMP). The oversized

medications have a correspondingly higher dosage level that could lead to a variety of

serious health complications, including death.

Some of the most cited adverse reactions to the defective Ethex products include:

• Bluish tint to skin and fingernails

• Coma

• Difficulty breathing

• Drowsiness

• Fainting

• Irregular heartbeat

• Low blood pressure

• Nausea

• Seizures

• Vomiting

• Weak pulse

The recalled medications had a wide range of intended uses. As such, the side effects of overdose differ significantly.

Consumers can view a full list of recalled drugs on the U.S. Food and Drug Administration Web site.

FEN PHEN

Fen Phen - Diet Drugs & Primary Pulmonary Hypertension (PPH)

Fen phen is a type of diet medication (anorectic) that was composed from a combination of

fenfluramine and phentermine; hence its "fen phen" classification. In 1997, it was reported by the Mayo Clinic that a significant number of fen phen users had developed heart valve disease as a result of using the anorectic. Continued reports of serious side effects associated with the use of fen phen resulted in a Food and Drug Administration (FDA) recommendation of a voluntary withdrawal of the appetite suppressant drug from US markets.

Fen phen was never approved for use by the FDA because its individual components

(fenfluramine and phentermine) had already been studied and approved by the

organization. The combination of the previously approved drugs fell under the heading of "off label use," meaning that there were no laws preventing such a use, though safety and efficacy had in no way been measured by the FDA.

Fen Phen Side Effects

There are a number of common side effects associated with the use of fen phen, most of which result from the individual components of fenfluramine and phentermine.

Common side effects associated with fenfluramine use include drowsiness, dry mouth and diarrhea; however, use of the drug could also result in: dizziness, confusion, nervousness, insomnia, constipation, abdominal pain, blurred vision, rash, fever, fainting, hypertension and heart valve disease.

Common side effects associated with phentermine use include headache, insomnia,

irritability and nervousness; however, use of the appetite suppressant could also result in: tremor, dryness of the mouth, palpitation, tachycardia, euphoria, gastrointestinal

disturbances, psychotic episodes, hypertension and heart valve disease.

Fen Phen Use & PPH

Fen Phen use has been linked with the development of a serious condition called primary pulmonary hypertension (PPH). The FDA recommended the voluntary withdrawal of Fen phen in September of 1997 following significant evidence of serious side effects associated with use of the drug, notably the drug's potential of causing heart valve defects and PPH.

Primary pulmonary hypertension results from a dangerously elevated blood pressure in the pulmonary artery (artery transporting blood from the heart to the lungs for oxygenation).

The dangerously elevated blood pressure forces the heart muscles to work harder to pump sufficient quantities of blood to the lungs. Over time, the heart muscles can become weakened to such an extent from overexertion that they fail, culminating in heart failure and death.

Although there are a number of known causes of PPH in addition to a number of unknown (idiopathic) causes, the link between the use of fen phen and the potential development of PPH was such that it warranted FDA action.

Fen Phen & Dexfen Phen

In addition to a fenfluramine and phentermine combination, patients were often

administered a dexfenfluramine and phentermine cocktail that was labeled as dexfen

phen. Like fen phen, dexfen phen has also been linked with the development of a number of serious health conditions.

Fenfluramine was first introduced to the US market in 1973 as a drug designed to

increase levels of a neurotransmitter called serotonin, depressing the central nervous

system and helping to moderate a patient's mood and appetite. As a single agent,

fenfluramine is also known by its brand name of Pondimin. Fenfluramine was withdrawn

from the US market in 1997.

Phentermine was approved for use in 1959 as an appetite suppressant for individuals

facing an increased medical risk as a result of their weight. Although phentermine has

been linked with the development of a number of side effects (including hypertension), it is currently still available for prescription as a single agent in the United States.

Dexfenfluramine was approved for use as an appetite suppressant in 1996 under the

brand name of Redux. Dexfenfluramine was manufactured as an alternative to both

fenfluramine and phentermine. Dexfenfluramine and Dexfen Phen (dexfenfluramine /

phentermine combination) were withdrawn because of the drugs' propensity towards

causing heart valve disease and pulmonary hypertension.

FLEET PHOSPHO-SODA

Fleet Laxatives Linked with Serious Kidney Injury and Other Side Effects

Several over-the-counter Fleet laxative products have been recalled by C. B. Fleet

Company after the Food and Drug Administration (FDA) received more than 20 reports of kidney injury caused by the products, including acute phosphate nephropathy — a serious type of renal damage.

The recall includes laxative products marketed under the names of Fleet Phospho-soda,

Fleet ACCU-PREP, Fleet EZ Prep, and Fleet Phospho-soda EZ Prep Bowel Cleansing

System.

Fleet Phospho-soda Black Box Warning

Fleet laxatives are over-the-counter oral sodium phosphate products commonly reserved for prescription use in preparation for bowel cleansing in surgery patients.

The FDA issued its first warning about Fleet Phospho-soda laxatives in May 2006, and

continued to increase the severity of its warnings until December 2008, when a black box warning (the FDA’s sternest warning) was issued for the products. In response to the black box warning, C.B. Fleet Company issued a voluntary recall of its products; however, the company is now considering re-releasing the under-fire laxatives to market. If C.B. Fleet Company does return the products to the U.S. market, it must repackage the laxatives — in accordance FDA regulation — to properly highlight the risk of kidney damage.

Severe Kidney Damage and Fleet Phospho-soda Products

Many patients who have taken the Phospho-soda oral laxative products have developed

signs of acute kidney injury, which include:

• Abdominal pain

• Decreased urine volume

• Diarrhea

• Difficulty concentrating

• Edema (swelling of ankles, feet and legs)

• Fatigue

• Lethargy

• Malaise

• Metallic taste in the mouth

• Nausea

In more severe cases, patients develop acute phosphate nephropathy, an accumulation of calcium-phosphate within the renal tubules that leads to acute renal failure.

The FDA has identified several risk factors for developing debilitating kidney failure after

taking Fleet laxatives, including:

• Active colitis

• Dehydration

• History of kidney disease

• Aged 55 years and older

• History of bowel obstruction(s)

• Use of diuretics, ACE inhibitors, ARBs, and NSAIDs

FOSAMAX

Fosamax Side Effects - Osteonecrosis and Femur Fractures

Fosamax is the brand name for alendronate, a type of bisphosphonate drug that is used in the treatment of a number of bone diseases, notably osteoporosis and osteitis deformans (Paget's disease).

Approved by the Food and Drug Administration (FDA) in 1995, Fosamax is manufactured by Merck & Co. With 2005 revenues exceeding $3 Billion, Fosamax is Merck & Co's second best-selling drug on the market. The fact that the drug has recently been linked with the onset of a serious bone condition called osteonecrosis of the jaw (ONJ), as well as with the risk of femur fractures, could spell disaster for Merck, who are currently involved in litigation surrounding Vioxx.

Osteonecrosis of the Jaw

In addition to the somewhat common and relatively mild side effects (headache, nausea, abdominal discomfort, rash, etc.) that are associated with the use of Fosamax, users face the risk of developing a serious condition called osteonecrosis of the jaw, or "dead jaw."

Fosamax users suffering from ONJ are susceptible to severe infections that can cause

facial discomfort, numbness or extreme pain. Swelling of the gums and poor gum health

can also be caused as a result of ONJ.

Osteonecrosis (avascular necrosis, aseptic necrosis, ischemic necrosis) is a type of bone disease that affects approximately 10,000 to 20,000 Americans each year. It commonly results from a temporary / permanent loss of blood flow to the bones. Without an adequate supply of blood, bone tissue cannot survive and will eventually die and lead to joint collapse.

Osteonecrosis Symptoms

The process of diagnosing osteonecrosis typically begins with a number of painful

symptoms that lead a sufferer to consult an orthopaedist, a doctor specializing in the

diagnosis and treatment of a variety of musculoskeletal conditions. The most common

osteonecrosis symptom is severe and chronic joint pain that is not unlike that suffered by arthritics. Although the time period between the initial onset of joint pain and the loss of joint functionality varies from one osteonecrosis sufferer to the next, it usually takes no longer than one year.

Diagnosing Osteonecrosis

If a case of osteonecrosis goes undetected and/or untreated, it can eventually cause a

great deal of arthritic pain while the joint surface erodes and the bone gradually collapses.

In order to determine whether someone eliciting symptoms of osteonecrosis is in fact

suffering from a case of the rare bone disease, a complete physical examination is

performed (functional evaluation of the bone) in addition to an evaluation of a patient's

medical history. Any number of bone imaging techniques (X ray, MRI, CT scan, bone

scan) are eventually employed in order to determine whether signs of osteonecrosis are

present.

In addition to bone imaging techniques and physical functionality examinations, an

orthopaedist may also request the surgical biopsy of bone tissue to determine whether it is receiving an adequate supply of blood.

Update - Fosamax Side Effects - Femur Fracture

In addition to osteonecrosis, there is increasing evidence that Fosamax also may cause

femur fractures in patients who take the drug for five years or longer. Although Fosamax is prescribed to strengthen bones, it actually may make bones more brittle when used for a long period of time. Women taking Fosamax have experienced femur fractures while performing relatively non-strenuous activities, such as descending stairs or engaging in low-stress exercises. The FDA notified Merck & Co. of this problem in 2008. However,

Merck waited 16 months to add the risk of femur fractures to its list of potential Fosamax

side effects, potentially placing additional patients at risk.

GADOLINIUM

Gadolinium Side Effects

The Food and Drug Administration (FDA) has asked the manufacturers of gadoliniumbased contrast agents to include a new boxed warning that alerts consumers of the potential development of NFS / NFD (Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy).

Those facing a significant risk of developing NSF / NFD include those suffering from

kidney malfunction or advanced renal failure, liver transplantation patients (preoperative & postoperative), and people suffering from chronic liver disease. Any such “at-risk” people are strongly advised to avoid gadolinium-based products to prevent NSF / NFD

development. Symptoms of NSF / NFD may begin to develop shortly after injection of a

gadolinium contrast agent, but may also take up to 18 months to fully develop.

What is NSF / NFD?

NSF / NFD is a disease of the skin and connective tissue. NSF / NFD sufferers may

experience significant thickening of the skin to the extent that joint mobility becomes

limited. Fibrotic scarring may also spread from its common areas to other parts of the body including the diaphragm, lungs, lower abdomen and muscles of the thigh. Although NSF /

NFD was not described in medical literature until 2000, the first case of the skin disease

was documented in 1997.

Gadolinium Contrast Agent Injuries

Gadolinium contrast agents are used to enhance the quality of an MRI scan. Although

gadolinium-based agents have proven to be extremely useful when used in conjunction

with MRI’s, they are also capable of eliciting some serious and potentially fatal side effects.

According to recent FDA reports, a single injection of gadolinium could potentially result in the development of NSF / NFD.

The most commonly used gadolinium contrast agent is OmniScan (gadodiamide);

however, there are five different types that have been approved for use by the FDA:

• OmniScan (gadodiamide)

• OptiMark (gadoversetamide)

• Prohance (gadoteridol)

• Magnevist (gadopentate dimeglumine)

• MultiHance (gadobenate dimeglumine)

GARDASIL

Gardasil HPV Vaccine - How Safe is it?

Gardasil is a drug developed by Merck & Co as a vaccine for certain strains of human

papilloma virus (HPV). The vaccine has recently come under scrutiny as a result of studies linking it with a number of potentially fatal side effects.

Marketed as a preventative measure against the spread of HPV-induced cervical cancer, Gardasil gained approval by the Food and Drug Administration (FDA) in 2006. Studies have determined that approximately 80% of all women will have been exposed to multiple strains of HPV by age 50. HPV vaccines like Gardasil have therefore been developed with the intent of providing a safeguard to women starting as early as age 11.

The unfortunate reality of such vaccines is that they may potentially do more harm than good. HPV vaccines like Merck & Co’s Gardasil have recently been added to the list of vaccines covered by the National Vaccine Injury Compensation Program (VICP). The vaccine compensation program was established in 1986 to provide monetary aid to victims of vaccine side effects.

Gardasil Side Effects

Although approved for use by the FDA, Gardasil has been associated with a number of

serious side effects. More than 3,400 complaints of serious Gardasil side effects and

complications have been registered, including eight deaths that are being investigated in relation to use of Merck & Co’s HPV vaccine.

Some of the commonly reported Gardasil side effects include:

• Blood clots

• Seizure

• Paralysis

• Bells palsy

• Guillain-Barre syndrome

Pregnant women taking the Gardasil vaccine have also reported experiencing serious side effects. Almost half of the pregnant women who received Merck & Co’s HPV vaccine experienced fetal abnormalities, the most serious of which resulted in spontaneous abortion.

HYDROXYCUT

Hydroxycut Recall – Liver Damage Side Effects

Iovate Science Incorporation has issued a recall of fourteen of its Hydroxycut products

following a warning from the U.S. Food and Drug Administration (FDA). The FDA and

Iovate Science Inc. are urging consumers to return the recalled products to their places of purchase after reports surfaced linking them to liver damage.

The FDA has received 23 reports of adverse side effects from consumers taking the

recommended dose of Hydroxycut products, including jaundice, elevated liver enzymes,

seizures, cardiovascular disorders and rhabdomyolysis – a type of muscle damage that

can lead to kidney failure. One death has also been reported to the FDA due to

Hydroxycut-related liver failure.

Hydroxycut products are over-the-counter dietary supplements believed to encourage

weight loss, including fat burners, energy enhancers, low carb diet aids and diuretics.

Recalled Hydroxycut Products

The list of recalled products includes:

• Hydroxycut Regular Rapid Release Caplets

• Hydroxycut Caffeine-Free Rapid Release Caplets

• Hydroxycut Hardcore Liquid Caplets

• Hydroxycut Max Liquid Caplets

• Hydroxycut Regular Drink Packets

• Hydroxycut Caffeine-Free Drink Packets

• Hydroxycut Hardcore Drink Packets (Ignition Stix)

• Hydroxycut Max Drink Packets

• Hydroxycut Liquid Shots

• Hydroxycut Hardcore RTDs (Ready-to-Drink)

• Hydroxycut Max Aqua Shed

• Hydroxycut 24

• Hydroxycut Carb Control

• Hydroxycut Natural

Healthcare professionals are investigating the claims against Hydroxycut to determine the ingredients that have led to increased risks of liver damage.

Januvia

Diabetes Medication May Be Linked to Pancreas Disorder

In September 2009, the Food and Drug Administration (FDA) began investigating

sitagliptin and its use in type 2 diabetes medications, Januvia and Janumet, after receiving reports of users developing acute pancreatitis.

From October 2006 to February 2009, the FDA received 88 reports of acute pancreatitis in patients using Januvia or Janumet, with two reports citing hemorrhagic pancreatitis and necrotizing pancreatitis.

Januvia, Janumet and Acute Pancreatitis

Januvia is an oral treatment of sitagliptin, while Janumet is an oral treatment of sitagliptin and metformin. Both medications control high blood sugar in type 2 diabetes patients who do not require daily insulin injections.

The FDA is urging physicians and consumers to exercise caution when using Januvia and Janumet, and is working with Merck and Company, the drugs’ manufacturer, to repackage the products to adequately highlight the warning.

Patients taking Janumet or Januvia are encouraged to carefully monitor their usage and to be aware of the symptoms of acute pancreatitis, which include:

• Abdominal pain that radiates to the back

• Fever

• Loss of appetite

• Nausea

• Oily stool

• Vomiting

Patients who develop any of the above symptoms while taking the drugs should consult

with their physicians to determine if Januvia or Janumet are right for them.

KETEK

FDA to Recommend Ketek Label Change

The FDA has recently issued an advisory to French pharmaceutical giants Sanofi-Aventis in regards to their respiratory infection drug, Ketek. The FDA issued the advisory amidst growing concern about the link between the use of Ketek and the development of potentially fatal liver damage.

The brand name for telithromycin, Ketek is the first ketolide antibiotic drug to be approved for clinical use. Ketek is used to help the body fight off infections related to certain respiratory ailments. The ketolide antibiotic drug interferes with protein synthesis of certain bacteria, preventing its growth and spread.

Ketek "Black Box" Warning

The FDA are currently working with Sanofi-Aventis officials to work out an agreeable way through which to properly warn Ketek patients about the grave health hazards that have recently been linked with use of the ketolide antibiotic. While the FDA does not yet believe the health concerns warrant a Ketek recall, it is of the opinion that labeling revisions should be implemented so as to adequately warn consumers about the risks related to liver damage.

One possible option that is being reviewed is the issuing of a "black box" warning for Ketek - a black box warning is the strongest warning that the FDA can place on a prescription drug. Ketek manufacturers refuse to concede that the antibiotic drug is unsafe for use,  claiming that any link between the onset of liver damage and Ketek use is likely attributed to incorrect use of the drug.

Ketek Side Effects - Ketek Liver Damage

Sanofi-Aventis has been under fire since January of 2006 because of certain links found

between the use of Ketek and the sudden onset of liver damage. According to an internal FDA memo, approximately 12 cases of liver damage resulting from Ketek use have thus far been established; four of which have resulted in patient death. The serious nature of this Ketek side effect has prompted FDA suggestion that Sanofi-

Aventis amend the drug's label so as to properly warn consumers of the risks associated with Ketek use.

In addition to the development of Ketek liver damage, the ketolide antibiotic drug has been linked with a number of other side effects, some of which include:

• Irregular heartbeat

• Fainting

• Allergic reaction

• Vision problems

• Mild nausea

• Headache

• Dizziness

Ketek and the FDA

The problems associated with serious Ketek side effects are furthered by the controversy the surrounded FDA approval of the ketolide antibiotic drug in 2004. Ketek had been disapproved twice by the FDA prior to 2004; once in 2001 and again in 2003.

The FDA claimed that both disapprovals were prompted by concerns regarding the safety of Ketek.

The FDA's eventual approval of Ketek caused a great deal of controversy. Charges were levied in regards to reports of faulty data that was produced from one of the Ketek clinical trials, bringing into question the grounds on which the drug was approved.

LEVAQUIN

Levaquin Side Effects - Tendon Ruptures Prompt Black Box Warning

A leading antibacterial drug has come under increased scrutiny by the Food and Drug

Administration following reports of serious injuries to tendons and ligaments linked with its use. Levaquin manufactured by Ortho-McNeil/Janssen is one of the antibiotics known as flouroquinolones, a class of commonly used antibacterial drugs. Levaquin is a third generation flouroquinolone, which was touted as an improvement and safer alternative to Cipro, an older second generation flouroquinolone.

Levaquin Black Box Warning

In light of the increased risks of tendon ruptures and ligament damage, the FDA has

issued a black box warning, the most urgent and severe type of safety warning imposed by the agency. Public Citizen petitioned the FDA for nearly two years following reports of Levaquin tendon rupture risks and other flouroquinolones.

Levaquin Ruptures

Tendon injuries most often result from some type of trauma or over-activity. Tendon tissue is located throughout the body; however, the most common tendon linked with

flouroquinolone-based rupture is the Achilles tendon. Reports indicate that the injury often occurred without pain or warning, suggesting a potential toxicity issue. Typically,

flouroquinolone injury victims reported pain and swelling prior to rupture, leading experts to believe that injury may be avoidable in such instances by halting use of the drug.

Levaquin tendon injuries have been shown to occur more often in patients over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. While the most common tendon injury associated with Levaquin has been an Achilles tendon rupture, there have been many reports of tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, and the thumb. Cases have also been reported which occurred up to several months after taking Levaquin.

MAALOX TOTAL RELIEF

FDA Warns of Maalox Total Relief Potential Safety Risks - Internal Bleeding

Swiss manufacturer of Maalox, Novartis, has agreed to change the name and packaging of its Maalox Total Relief medication following an FDA request. According to federal regulators, consumers have been confusing Maalox Total Relief with its gentler formula used to neutralize stomach acid.

In addition, Novartis is being asked to provide patients and physicians with educational

seminars explaining the difference between the products and how to avoid confusing the two. This also may help to select between other Maalox products.

The rebranded Maalox Total Relief is expected in September 2010.

Maalox Total Relief Safety Risks – Clotting and Internal Bleeding

Maalox Total Relief contains bismuth subsalicylate, a chemical similar to aspirin which can lead to internal bleeding in patients with stomach ulcers and blood clotting issues.

The FDA also warns that Maalox Total Relief could pose serious health risks to children.

The more potent version of the product also can negatively interact with certain blood

thinners, including Warfarin and Plavix, as well as anti-inflammatory drugs such as aspirin.

Both Maalox and Maalox Total Relief are over-the-counter medications.

MASS EXTREME

Tren and Mass Extreme Side Effects: Liver Failure

Consumers across the country are being urged to stop using dietary supplements amid a massive recall of Tren Xtreme and Mass Extreme. The FDA recall follows a guilty plea

from the supplements’ California based manufacturer, VMG Global, also known as

American Cellular Labs. The plea states that VMG Global illegally spiked their

supplements with steroids. According to the FDA, use of the two supplements may lead to serious injury, including liver failure.

Tren and Mass Extreme Steroid Controversy

Although Tren and Mass Extreme were being marketed as dietary supplements, they are unapproved and misbranded drugs that contain synthetic steroid substances known to cause harm. Between 2005 and 2009, the two products generated $5.6 million in revenue for VMG Global.

VMG has agreed to pay up to $500,000 in penalties and destroy its inventory of two drugs.

Supplemental Recall of Dietary Supplements

Although the first to plead guilty, the FDA says that VMG may not be the only company

selling misleading dietary supplements. In fact, over the last 12 months the FDA has been warning consumers to avoid using any body-building supplements due to concerns that some may contain harmful and unidentified steroids resulting in serious health risks.

MuscleMaster.com has announced a recall of 17 dietary supplements following an FDA

investigation. A press release from the company said it could not confirm that the products contained steroids and had not received any reports of injury, but had recalled the products out of caution.

MERIDIA

Meridia Risks - Increased Heart Attack and Stroke Risks

Patients using the prescription drug Meridia are being asked to contact the Food and Drug Administration (FDA) and report any side effects. This comes after a new study revealed that Meridia, (sibutramine hydrochloride) prescribed to overweight patients who may be at risk for diabetes, high cholesterol and high blood pressure, may increase the risk of heart attack, stroke or other cardiovascular problems.

The study is currently being reviewed by FDA regulators who have released an early

communication based on the data. Although the FDA has promised to announce any

regulatory action as soon as possible, the agency has advised doctors and their patients to follow the current guidelines, which recommend against using Meridia in people with a history of cardiovascular conditions.

The study included approximately 10,000 people aged 55 or older, with a history of heart disease or diabetes, and one additional risk factor for cardiovascular problems.

Approximately 5,000 people were asked to take Meridia while the other half received a

placebo pill. Serious cardiovascular events occurred in:

• 11.4% of people taking Meridia

• 10% of individuals taking a sugar pill

The difference is higher than expected and strongly suggests that sibutramine is

associated with an increased cardiovascular risk.

The manufacturer of sibutramine says that Meridia is safe when used as recommended.

The analysis of the data is ongoing and is being conducted by the FDA as well as the

manufacturer.

The FDA is asking patients who are currently using Meridia to consult their doctor before discontinuing use.

Meridia Side Effects

Meridia is generally prescribed to people with a body mass index of 30 and higher to assist in weight management. The drug affects the patient’s brain to help them feel full, thus eat less.

A number of patients who have taken Meridia have developed side effects, the most

common of which include:

• Increased heart rate and blood pressure

• Throbbing heart beat

• Difficulty breathing

• Nausea

• Abdominal pain

• Anxiety and mood swings

• Fever

• Swelling

• Tingling skin sensation

NEXIUM

Certain Proton Pump Inhibitors Linked with Hip Fracture

A recent study conducted in the United Kingdom has discovered a link between use of

certain proton pump inhibitors (heartburn drugs) and an increased potential of hip fracture in people over 50. Proton pump inhibitors are used to limit the amount of acid that is secreted in the stomach. The study determined that acid reduction can aid in heartburn relief while also having a negative effect on the body's ability to absorb calcium. Without an adequate intake of calcium, the bones weaken and become more susceptible to fracture or break.

Findings from the British study were published in a December 2006 issue of the Journal of the American Medical Association. It evaluated the medical records of more than 145,000 proton pump inhibitor patients throughout England with an average age of 77. It was concluded that patients taking these drugs for more than a one year period faced a 44 percent increased risk of suffering hip fracture.

8.12.08 - Results from a new study published in the Canadian Medical Association Journal have found a conclusive link between the prolonged use of powerful proton pump inhibitors like Prilosec, Nexium and Prevacid, and a higher risk of bone fracture.

The Canadian study evaluated 16,000 patients aged 50 and over who had suffered hip

fracture, along with a control group of 47,000 patients aged 50 and over with no history of bone fracture. The two groups were assessed based on proton pump inhibitor use.

People taking proton pump inhibitors for five years are two-times more likely to suffer bone fracture. People taking proton pump inhibitors for more than seven years are four-times more likely to suffer bone fracture.

Although the Canadian study does not find a causative relationship between proton pump inhibitor use and bone fracture, it nonetheless does verify a relationship between the two.

It has been hypothesized that the bone fracture could be related to calcium deficiency.

Antacids neutralize powerful acids in the stomach. Hydrochloric acid is believed to play an integral role in the body’s absorption of calcium, a mineral necessary in bone health.

Prolonged use of antacids could inhibit hydrochloric acid production, in turn inhibiting

calcium absorption.

Proton pump inhibitor users should speak with their doctor to discuss their options.

Oftentimes, the powerful antacids are prescribed inappropriately when a more basic option is available.

Representatives from some of the most popular proton pump inhibitor manufacturers

argue that the link between their heartburn drugs and hip fracture is nothing more than a

"potential association." It is argued that doctors are responsible for monitoring the health

and wellbeing of their patients to prevent issues related to insufficient bone density levels.

Proton pump inhibitors have proven to be an effective treatment for chronic heartburn

sufferers. It may simply be a matter of finding an adequate balance between use of the

drugs and a calcium-rich diet.

Common Heartburn Drugs and Hip Fracture

The heartburn drugs in question are Nexium, Prevacid and Prilosec, three of the most

popular proton pump inhibitors on the market. Although the link is not entirely clear, it is

believed that people over 50 who take these drugs for a period longer than one year

significantly increase their risk of suffering hip fracture. Men are viewed to be at a greater risk than women because women are more prone to a lifestyle that incorporates a calcium rich diet, offsetting some of the concerns associated with proton pump inhibitors.

The Prevalence of Proton Pump Inhibitors

Proton pump inhibitors are some of the most commonly prescribed drugs because of the prevalence of heartburn in the United States. It is estimated that there are millions of

people throughout the country currently taking Nexium, Prevacid or Prilosec. Nexium is in fact the second best selling drug in the world, with revenues exceeding $4.6 Billion in

2005. For people suffering from chronic heartburn, proton pump inhibitors like Nexium,

Prilosec and Prevacid, represent one of the only means through which to experience relief from the bothersome heartburn effects.

NUVARING

NuvaRing Birth Control Device Linked with Blood Clots

The NuvaRing is the latest contraceptive under fire as a result of reports linking it with

blood clots. Manufactured by Organon USA, the NuvaRing is a type of hormonal

contraceptive developed as an alternative to oral contraceptives and the birth control

patch.

NuvaRing was approved for use by the Food and Drug Administration in 2001. The

contraceptive is a vaginal ring designed to release progesterone and estrogen over a

three-week period to prevent pregnancy. After three weeks, the NuvaRing can be removed for one week, before starting the process over again.

Organon USA was purchased by multinational pharmaceutical company Schering Plough in November of 2007. In addition to gaining the rights to all Organon USA products, Schering Plough also assumed any associated liabilities.

NuvaRing Stroke Injury

A wrongful death lawsuit has been filed on behalf of a New Jersey woman who died

suddenly after starting to use the NuvaRing. The lawsuit was filed by her husband who

claims that she died “overnight” as a result of a blood clot that he believes was brought on by the NuvaRing.

The lawsuit, which also names Schering Plough, is just one of many that have been filed against the manufacturers of the NuvaRing. As a hormonal contraceptive, the NuvaRing poses certain risks, including blood clots, stroke, heart attack and breast cancer. There has even been a lawsuit filed against NuvaRing on the basis that it caused toxic shock syndrome, a bacterial condition that has been linked with the prolonged use of tampons.

NuvaRing representatives have refused to accept responsibility for any wrongdoing

associated with the safety of their product, claiming that the NuvaRing poses no more risks than other hormonal contraceptives.

Hormonal Contraceptives and the Blood Clot Connection

NuvaRing is the latest hormonal contraceptive to be targeted by personal injury litigation.

Ortho Evra, the hormonal contraceptive patch, has also been a recent target as women

using it experienced an increased risk of blood clotting and stroke. Blood clotting, or

venous thrombosis, has long been associated with hormonal contraceptives. In many

cases, the risks are minimal, though some of the newer hormonal contraceptives have

been targeted because of an increased risk factor.

The FDA has been petitioned on behalf of more than 100,000 consumers throughout the United States to recall and ban the use of third generation oral contraceptives that contain the deogestrel molecule linked with blood clots.

ORTHO EVRA

Ortho Evra

The Ortho Evra birth control skin patch is a weekly hormonal contraceptive that is worn on the skin to prevent pregnancy. The skin patch is worn for one week and replaced on the same day of the week for three consecutive weeks. No skin patch is required for the fourth week. The skin patch releases progestin (synthetic hormone) and estrogen (female sex hormone) through the skin and into the bloodstream.

The Ortho Evra skin patch helps prevent ovulation (eggs released by the ovary for

fertilization). The hormones cause a thickening of the cervical mucus to prevent sperm

from entering the uterus. The patch impedes the implantation of fertilized eggs in the

uterus.

Application of the Patch

The Ortho Evra skin patch can be placed on four areas of the body. Women can apply the patch to the upper outer arm, upper torso (front or back, excluding the breasts), abdomen, and buttocks. The patch can be worn in a different area of the body each week. The patch should not be placed on areas of the skin where makeup will be applied or on irritated or cut skin.

Three separate Ortho Evra skin patches should be applied during a menstural cycle. To

ensure protection, the patch should be changed on the same day of each week. If the

patch is applied after the designated day, then additional contraception is recommended

prior to intercourse.

Ortho Evra Side Effects

The skin patch side effects are similar to other synthetic hormonal contraceptives. Side

effects include breast discomfort, painful menstural cycles, headaches, and nausea. The discomfort in the breasts will reduce after each completed skin patch cycle.

Females will notice an increase in their menstural bleeding. The intensity of the menstural bleeding will decrease over time. All side effects should clear up after three consecutive patch cycles.

Women missing their period for consecutive patch cycles should consult their gynecologist. The user may be pregnant or suffering from amenorrhea. Amenorrhea is an absence of the menstural cycle. The treatment can range from lifestyle changes (diet, exercise, or stress reduction) to surgery (removal of vaginal or uterine obstruction).

Ortho Evra Complications

Reports indicate women who wear the Ortho Evra skin patch are exposed to a higher level of estrogen than women using birth control pills. Higher levels of estrogen in the

bloodstream have been linked to blood clots in the legs and lungs. These blood clots can lead to heart attack and stroke. The Ortho Evra blood clot risk is increased by women who smoke, and have family history or blood disorders.

A blood clot occurs when blood is converted from a liquid to a solid state. The clot can limit or stop the flow of blood to important organs, such as the heart or brain. The blockage can cause a heart attack or stroke. A heart attack occurs during blockage of blood vessels in the heart and a stroke occurs during blockage or rupture of blood vessels in the brain.

Medication can be used to break up the clotting in the blood vessels.

Although, young women have a low risk for blood clot related conditions, reports indicate patch users suffering from blood clots are dying at a higher rate than women using birth control pills. The majority of the women are in their late teens to early twenties.

PAXIL

Paxil, or known by its generic name paroxetine, is prescribed for the treatment of

depression, anxiety disorders, obsessive-compulsive disorders (OCD), and panic disorder.

Paxil is helpful in treating depression in its early stage, before the disorder becomes

deeply rooted. Paxil has become the most widely used SSRI (selective serotonin reuptake inhibitor) for treating anxiety disorders. SSRIs are a class of antidepressant drugs.

Types of Illnesses

Each anxiety disorder has its own distinct features, but they are all bound together by the common theme of uncontrollable worry about everyday tasks. Approximately 19 million Americans are affected with some type of anxiety disorder. The patient's condition will deteriorate if not treated.

Obsessive-compulsive disorder (OCD) is a disorder that disrupts the brain's interpretation process. 1 in 50 adults are diagnosed with OCD. In OCD, the brain becomes fixated on a particular thought or urge. Examples include hours of hand washing or continually driving around a block before stopping the vehicle. Very effective treatments are available to help return the behavior to normal.

Depression interferes with a person's ability to carry on with daily tasks and enjoy activities that brought pleasure. Symptoms of depression include feelings of sadness,

hopelessness, changes in appetite or sleep patterns, low energy, and difficulty in

concentrating. Antidepressant drugs reduce the symptoms and allow the depressed

person to regain an interest in their previous surroundings.

Paxil and Other Treatments

The mind transfers thoughts and feelings through nerve cells or neurons in the central

nervous system. These messengers are called neurotransmitters. Experts believe that an imbalance in neurotransmitters causes depression. Paxil treats depression by eliminating this imbalance in neurotransmitters.

Some symptoms diminish early into treatment. The first sign of improvement is a decrease in the lethargy and amotivation experienced by the patient during their depression. This effect occurs before the depression itself improves; the patient may be able to develop enough energy and motivation to renew their daily schedule. Different medication may be prescribed if reduction of symptoms is not noted within five to six weeks.

Paxil Withdrawal Symptoms

Anxiety disorders are not permanent conditions; therefore short term and long term

treatment options are available. Researchers have concluded that withdrawal symptoms

are present when patients abruptly stops taking Paxil and other SSRIs. Withdrawal

symptoms include extreme dizziness and "zaps" (an electro-shock like sensation to the

brain). To ease or eliminate these withdrawal symptoms, it is recommended that the

patient reduce dosage levels over time. Withdrawal from paroxetine or any other SSRI

medication without supervision is not advised.

Paxil Side Effects

There is evidence of increased suicidal risk and deepened depression in people taking

Paxil. The patient becomes easily agitated and sudden impulses turn deadly, after

beginning their medication. A high number of patients who have taken Paxil have

committed suicide.

Studies indicate an association between birth defects and woman taking Paxil during the first trimester of their pregnancy. Cardiovascular birth defects have doubled in babies delivered by mothers taking Paxil. A higher degree of caution is warranted when pregnant women are using Paxil. Read more about Paxil side effects.

PERMAX

Parkinson's Drugs Linked with Valvular Heart Disease

Recent studies have determined a causative link between the use of certain ergot-derived dopamine agonists and the development of valvular heart disease. The link is such that antiparkinsonian drug users are being warned of the potential dangers associated with such treatments.

Ergot-derived dopamine agonists are typically used to provide symptomatic relief for

people suffering from Parkinson's disease. A neurodegenerative disease, Parkinson's is

caused by a dopamine imbalance. Dopamine agonists serve as a type of artificial filler

designed to correct this imbalance and reduce its resulting effects. Although the drugs

have proven capable of yielding positive benefits, the serious nature of the valvular heart disease has prompted a great deal of concern.

Pergolide, Cabergoline and Valvular Heart Disease

There are a number of different ergot-derived dopamine agonists used in Parkinson's

treatment, two of which have been implicated in the development of cardiac-valve

regurgitation (leaky heart valves): Pergolide and cabergoline. Pergolide is marketed under the brand name of Permax by Eli Lilly and cabergoline is marketed under the brand name of Dostinex and Cabaser by Pfizer. Studies conducted in the United Kingdom and Italy took into account the cases of more than 11,400 patients taking antiparkinsonian medication. The studies concluded that patients taking pergolide and cabergoline face an increased risk of developing valvular heart disease.

It is believed that use of the aforementioned ergot-derived dopamine agonists can interfere with the 5-HT2B receptor, potentially impairing heart valve functionality. Pergolide in particular has proven capable of eliciting fibrotic changes in valve "leaflets" that can result in the stiffening of valves and valve regurgitation. Such fibrotic changes can have fatal consequences.

PREMPO

A Philadelphia Jury Awards $9.45 Million to Breast Cancer Victim Using HRT Drug

Wyeth Pharmaceuticals has lost another personal injury case, following a lengthy trial in

Philadelphia during which the plaintiff was able to prove that the drug maker's popular

hormone replacement therapy drug, Prempro, caused her breast cancer. This marks the

seventh loss for Wyeth in a string of personal injury lawsuits claiming the manufacturer

knew about the risks associated with the drug, yet failed to warn consumers.

A Philadelphia jury ordered Wyeth to pay $6 million in punitive damages to the woman's

family, and an additional $3.5 million in compensatory damages. The woman's husband

also is to receive loss of consortium damages in the amount of $200,000, bringing the total to $9.45 million.

According to the lawsuit, Prempro (a popular HRT drug) was one of the causes of Audrey Singelton's breast cancer. The retired school bus driver was on the medication for seven years before she was diagnosed with cancer.

A damaging piece of evidence believed to have swayed the jury was an internal letter from Charles H. Payne, a Wyeth manager in Alabama, who wrote that "the desire for increased sales has overruled our company's ethical responsibility to promote our products safely."

Prempro History

In 2002 a major federal study found that Prempro, designed to relive menopausal

symptoms in women, may be a contributing factor in causing breast cancer, heart attack

and stroke. Although, the FDA and the National Institutes of Health held nationwide public forums to help patients and doctors digest the results of the study, Prempro was never taken off the market. In fact, there was a general recommendation to continue taking the drug. More than six million women took the pills to treat symptoms such as hot flashes and mood swings.

Until 1995, many patients combined Premarin, Wyeth's estrogen-based drug, with

progestin-laden Provera, made by Pfizer's Pharmacia & Upjohn unit. Wyeth combined the two hormones in Prempro. Last year, New York-based Pfizer, the world's largest drug manufacturer, bought Wyeth for $68 billion.

PRILOSEC

Certain Proton Pump Inhibitors Linked with Hip Fracture

A recent study conducted in the United Kingdom has discovered a link between use of

certain proton pump inhibitors (heartburn drugs) and an increased potential of hip fracture in people over 50. Proton pump inhibitors are used to limit the amount of acid that is secreted in the stomach. The study determined that acid reduction can aid in heartburn relief while also having a negative effect on the body's ability to absorb calcium. Without an adequate intake of calcium, the bones weaken and become more susceptible to fracture or break.

Findings from the British study were published in a December 2006 issue of the Journal of the American Medical Association. It evaluated the medical records of more than 145,000 proton pump inhibitor patients throughout England with an average age of 77. It was concluded that patients taking these drugs for more than a one year period faced a 44 percent increased risk of suffering hip fracture.

8.12.08 - Results from a new study published in the Canadian Medical Association Journal have found a conclusive link between the prolonged use of powerful proton pump inhibitors like Prilosec, Nexium and Prevacid, and a higher risk of bone fracture.

The Canadian study evaluated 16,000 patients aged 50 and over who had suffered hip

fracture, along with a control group of 47,000 patients aged 50 and over with no history of bone fracture. The two groups were assessed based on proton pump inhibitor use.

People taking proton pump inhibitors for five years are two-times more likely to suffer bone fracture. People taking proton pump inhibitors for more than seven years are four-times more likely to suffer bone fracture.

Although the Canadian study does not find a causative relationship between proton pump inhibitor use and bone fracture, it nonetheless does verify a relationship between the two.

It has been hypothesized that the bone fracture could be related to calcium deficiency.

Antacids neutralize powerful acids in the stomach. Hydrochloric acid is believed to play an integral role in the body’s absorption of calcium, a mineral necessary in bone health.

Prolonged use of antacids could inhibit hydrochloric acid production, in turn inhibiting

calcium absorption.

Proton pump inhibitor users should speak with their doctor to discuss their options. Oftentimes, the powerful antacids are prescribed inappropriately when a more basic option is available.

Representatives from some of the most popular proton pump inhibitor manufacturers

argue that the link between their heartburn drugs and hip fracture is nothing more than a

"potential association." It is argued that doctors are responsible for monitoring the health

and wellbeing of their patients to prevent issues related to insufficient bone density levels.

Proton pump inhibitors have proven to be an effective treatment for chronic heartburn

sufferers. It may simply be a matter of finding an adequate balance between use of the

drugs and a calcium-rich diet.

Common Heartburn Drugs and Hip Fracture

The heartburn drugs in question are Nexium, Prevacid and Prilosec, three of the most

popular proton pump inhibitors on the market. Although the link is not entirely clear, it is

believed that people over 50 who take these drugs for a period longer than one year

significantly increase their risk of suffering hip fracture. Men are viewed to be at a greater risk than women because women are more prone to a lifestyle that incorporates a calcium rich diet, offsetting some of the concerns associated with proton pump inhibitors.

The Prevalence of Proton Pump Inhibitors

Proton pump inhibitors are some of the most commonly prescribed drugs because of the prevalence of heartburn in the United States. It is estimated that there are millions of

people throughout the country currently taking Nexium, Prevacid or Prilosec. Nexium is in fact the second best selling drug in the world, with revenues exceeding $4.6 Billion in

2005. For people suffering from chronic heartburn, proton pump inhibitors like Nexium,

Prilosec and Prevacid, represent one of the only means through which to experience relief from the bothersome heartburn effects.

PROCRIT

FDA Investigates Epogen, Aranesp & Procrit Anemia Drugs Side Effects

The Food and Drug Administration (FDA) is set to form an independent panel of experts to re-evaluate the safety of three major anemia drugs, Epogen, Aranesp and Procrit. Agency officials say they expect to release new dosage and warning labels over the next several months.

The FDA decision comes one month after a recent study raised major safety concerns,

indicating that the anemia drugs — sold by Amgen and Johnson & Johnson — may double the risk of stroke and heart attack at current dosage levels.

Epogen, Aranesp and Procrit Side Effects

Epogen, Aranesp and Procrit are frequently prescribed to patients suffering from diabetes and chronic kidney disease. The popular anemia drugs also are commonly prescribed to cancer patients following chemotherapy treatments. In addition, the study indicates that the drugs may worsen the survival rate of certain cancer patients.

The FDA panel is set to re-evaluate whether patients should be given lower doses of

anemia drugs and how this may help decrease current health risks associated with

Epogen, Aranesp and Procrit.

In the meantime, the sales of anemia drugs continue to decline, while Amgen claims the

clinical trials are based on lack of understanding on how anemia drugs work. In addition,

both drug companies have admitted paying millions of dollars to doctors in return for

prescribing their patients anemia medicine. The total amount of payments has yet to be

disclosed by Amgen and Johnson & Johnson, as the FDA prepares to further investigate the safety of all three drugs.

Anemia drug users are advised to discuss their options with their physician to determine

the best course of action.

PROTOPIC

Protopic and the FDA 'Black Box' Warning

Protopic use has recently been linked with the possible development of lymphoma and/or skin cancer. While a causative link between Protopic and cancer remains inconclusive, initial data is such that it has led the FDA to issue a new safety warning with regards to use of the immunosuppressive drug. The FDA began to take notice of the possible relationship between skin cancer, lymphoma and Protopic use in 2005.

Efforts made by the FDA to institute significant warning label changes were met with resistance by Astellas, the manufacturers of the drug. However, in January of 2006, the FDA required that Protopic be labeled with a "black box" warning advising patients and doctors with regards to the serious nature of Protopic side effects.

About Protopic

Protopic is the brand name for tacrolimus (FK-506 / Fujimycin), an immunosuppressive

drug approved by the FDA in 2000. Developed by Fujisama Healthcare Inc. (Astellas),

Protopic has recently garnered a great deal of negative publicity with regards to its

potential link with cancer.

Immunosuppressives are used to diminish immune system response when such a

response is believed capable of eliciting a negative effect. For example,

immunosuppressives like Protopic are used after allogenic organ transplantation (donor

transplantation) to prevent the immune system from attacking the newly transplanted

foreign cells; such an attack could result in organ rejection.

The immunosuppressant nature of Protopic can weaken a patient's immune system to

such an extent that they become increasingly susceptible to the development of a variety of diseases and cancers.

Protopic is similar in nature to another type of topical immunosuppressant that has recently come under FDA fire because of its possible link with cancer; Elidel (pimecrolimus). Both drugs are used to treat atopic eczema and both have recently been required to include "black box" warnings on their labels to make patients and doctors fully aware of the possible side effects associated with use.

Protopic Ointment

Protopic is commonly used in a topical preparation designed to treat severe cases of

atopic dermatitis / atopic eczema, an allergic inflammation of the skin. Protopic treats

atopic dermatitis in a similar manner to steroids in that it suppresses inflammation;

however, Protopic is significantly weaker than steroids. Unlike steroids, the weaker

Protopic Ointment does not cause a thinning of the skin (skin atrophy) and can therefore

be used on areas of the body where the skin is already thin (like the face). Protopic has

therefore become an increasingly popular topical immunosuppressant.

People using Protopic are at risk of developing a number of side effects. As such, the

immunosuppressive is indicated for use as a "second-line" therapy for short-term treatment of atopic dermatitis. I.E, it is only recommended for use after other therapies have proven unsuccessful.

Protopic Side Effects

There are a number of side effects that have been associated with the use of Protopic

Ointment in the treatment of atopic dermatitis, some of which include:

• Burning skin sensation

• Headache

• Flu-like symptoms

• Severe itching of the skin (pruritus)

• Cancer

PROVIGIL

Provigil Side Effects

Provigil is a brand name for modafinil, a type of stimulant used for the treatment of sleep

disorders and excessive sleepiness. Developed by Cephalon Inc. Provigil is designed to

improve the alertness of its users while suppressing their need for sleep.

Although Provigil has proven effective in providing treatment for various sleep disorders, it has also been linked with the development of a serious side effect: Stevens Johnson

Syndrome (SJS). This immune-complex-mediated hypersensitivity condition causes

sufferers to experience inflammation of the skin and mucous membranes. Serious cases of SJS may be fatal.

FDA Issues Provigil Warning

The FDA has issued a warning to physicians and consumers about this potential link,

advising Provigil patients to consult their doctor immediately if they develop a skin rash or experience another form of hypersensitivity.

Provigil is one of Cephalon’s most popular drugs. The pharmaceutical company recently

gained FDA approval for a new drug designed to treat similar sleep-related conditions.

The drug, Nuvigil, has already been linked with some of the same warnings that have been applied to Provigil. Patients taking Provigil or Nuvigil should consult their doctor to

determine whether to discontinue use of the drug.

Clinical Application of Provigil

Provigil was approved by the FDA in 1998. It may be prescribed for the treatment of a

number of sleep-related conditions, including:

• Narcolepsy

• Shift work sleep disorder (SWSD)

• Obstructive sleep apnea / hypopnea syndrome (OSAHS)

Physicians have also been known to prescribe Provigil for a number of off-label uses,

including treatment of attention-deficit disorder (ADD) and attention-deficit hyperactivity

disorder (ADHD), depression, general fatigue, multiple sclerosis, Alzheimer’s disease and cocaine addiction.

RAPAMUNE

Rapamune Side Effects Prompt FDA Investigation

Rapamune users have been advised to consult with their physician following reports

linking the immunosuppressant with serious adverse effects, including diabetes and death.

The Food and Drug Administration (FDA) issued the warning on June 11, 2009, in

response to a recent study conducted by Rapamune manufacturer Wyeth

pharmaceuticals.

Rapamune, or sirolimus, is FDA approved for the management of hemolytic-uremic

syndrome (HUS) following kidney transplantation. Patients suffering from HUS who are

faced with kidney transplantation may be prescribed Rapamune to prevent recurrence of the serious condition. In addition, many doctors prescribe the drug to patients receiving a liver transplant. This off-label use of the anti-organ transplant rejection drug has been linked with an increased risk of death, spurring an FDA investigation.

Rapamune Death

Liver transplant patients prescribed Rapamune to prevent donor organ rejection face an

increased risk of death according to a study conducted by Wyeth. Results suggest that the potential for liver rejection is “significantly higher” in patients treated with Rapamune

versus those with a more traditional calcineurin inhibitor (CNI)-based immunosuppressant.

According to the study, more liver transplant patients were forced to discontinue use of

Rapamune due to adverse effects compared with those receiving CNI treatment. The FDA is evaluating whether to further adjust the labeling requirements for Rapamune, which already carries a “black box” warning, the most serious leveled by the federal agency.

In addition to liver rejection, the Wyeth study also highlighted frequent Rapamune side

effects that include:

• Rash

• Stomatitis

• Peripheral edema

• Mouth ulcerations

The FDA advises against the use of Rapamune immediately after liver transplantation.

Patients prescribed Rapamune should consult with their physician for further information

before discontinuing use.

Rapamune and Diabetes

A July 2008 study published in the Journal of the American Society of Nephrology linked

Rapamune with an increased risk of diabetes. According to the study, the side effects

caused by Rapamune use increases the likelihood of diabetes by 36 percent.

RAPTIVA

Raptiva Side Effects – Raptiva Recall

Raptiva (efalizumab) is being recalled by its manufacturer, Genentech Incorporation, after reports linking the plaque psoriasis drug to a rare brain infection. The Food and Drug Administration (FDA) has issued a public health advisory and a "black box" warning, the sternest FDA warning. In response, Genentech Inc. is withdrawing Raptiva from U.S. markets.

Raptiva is an injectable immunosuppressant that treats plaque psoriasis, a chronic

autoimmune disease that affects the skin and joints. The drug is recommended to be used weekly in adults older than 18 years. Research has suggested that prolonged use of Raptiva in those younger than 18 years old could lead to a permanently suppressed

immune system.

Raptiva Brain Infection - Progressive Multifocal Leukoencephalopathy (PML)

The FDA has received several reports that suggest a correlation between Raptiva and

several life-threatening infections, including bacterial sepsis, viral meningitis, invasive

fungal disease and progressive multifocal leukoencephalopathy (PML).

There have been three confirmed deaths due to PML in Raptiva patients. Many suspect

Raptiva suppresses the immune system to an extent that leaves users vulnerable to

several serious infections, especially PML.

PML Symptoms

PML is a very rare brain infection caused by a virus that affects the central nervous

system. Symptoms of PML include:

• Weakness

• Loss of coordination

• Changes in vision

• Personality changes

• Difficulty speaking

PML typically occurs in those with acquired immune deficiency syndrome (AIDS) or those undergoing immunosuppressive therapies.

REGLAN

Reglan Linked to Side Effects Resembling Parkinson's Disease

Wyeth Incorporated is facing a slew of personal injury lawsuits stemming from Reglan side effects. Reglan is widely used for the treatment of various gastrointestinal problems, however, Food and Drug administration (FDA) scrutiny has prompted concerns over a potential recall. The FDA is evaluating a suspected failure on the part of Wyeth to issue adequate warning to doctors and consumers informing them of potentially serious Reglan side effects, including tardive dyskinesia

According to the latest "black box warning," a Reglan ingredient called metoclopramide

has been linked to a wide range of serious and permanent movement disorders.

Reglan Side Effects

Recent studies indicate that Reglan, when used long-term or in high-doses, may cause

tardive dyskinesia. Patients suffering from this devastating condition often experience the following symptoms:

• Rapid eye movements

• Impaired movement of facial expressions

• Grimacing

• Pursing of the lips

• Tongue protrusion

According to a report issued by the FDA, high risk patients include the elderly and those

who have been on the drug for a long period of time. Furthermore, the FDA warns that

tardive dyskinesia as a result of Reglan use may develop long after patients discontinue

using the drug. In fact, recent FDA analysis of a metoclopramide study concluded that

approximately 20 percent of patients taking Reglan were on the drug for longer than three months.

REMICADE

Remicade – Inflammatory Drugs – Increased Risk of Childhood Cancer - updated

08.04.09

The Food and Drug Administration (FDA) has issued a "black box" warning for several of the top-selling arthritis and inflammatory drugs in the United States. Humira, Remicade, Enbrel and Simponi received the FDA's sternest warning after reports surfaced suggesting the medications increase the risk of cancer in children.

The prescription drugs are FDA-approved to treat Crohn's disease, inflammatory bowel

disease and arthritis in children, adolescents and adults.

Side Effects of Arthritis Drugs, Including Remicade

After reviewing the medications for a year, the FDA concluded that children and

adolescents who take the inflammatory drugs for more than two and a half years have an increased risk of developing cancer. Of the several dozen reports of childhood cancer, more than half of those were lymphoma cases – a serious form of cancer that attacks the immune system.

Parents of children who are taking one of the four medications should carefully monitor

their children for any of the following symptoms of cancer:

• Difficulty breathing

• Facial swelling

• Fatigue

• Fever

• Itchiness

• Loss of appetite

• Night sweats

• Painless lumps (enlarged lymph nodes)

• Weight loss

Children who demonstrate any of the aforementioned conditions should be taken to a

physician for an evaluation.

Parents should not stop administering the arthritis and inflammatory medications to their

children unless instructed to do so by their physician.

In addition to working with the drug manufacturers to update their packaging, the FDA is

mandating that the companies must supplement their medical guides with information

about the increased cancer risk.

Histoplasmosis - Remicade, Humira, Enbrel Linked to Infection

Histoplasmosis is an infection caused by the inhalation of airborne spores of the

Histoplasma capsulatum fungus. Histoplasmosis, also known as Darling’s disease,

primarily affects the lungs; however, it sometimes spreads throughout the body and can

cause severe damage.

Patients with histoplasmosis typically do not exhibit symptoms, which can hinder patients receiving necessary medical attention. Because the fungus spores are present in soil, histoplasmosis primarily affects farmers and other people working in or around soil in the Eastern and Midwestern areas of the United States.

The Food and Drug Administration is investigating claims against several rheumatoid

arthritis drugs that are believed to make patients susceptible to histoplasmosis. Humira,

Remicade and Enbrel treat arthritis patients by suppressing the immune system, which

consequently leaves patients vulnerable to infection.

Approximately 240 cases of histoplasmosis have been reported in patients taking these

drugs, with approximately 20 percent resulting in death. Patients taking one of these three drugs who demonstrate flu-like symptoms should seek immediate medical attention to prevent the potentially devastating consequences of histoplasmosis.

Humira, Enbrel and Remicade are used to treat some of the two million Americans

suffering from rheumatoid arthritis. Although the drugs have had some success in

providing relief for rheumatoid arthritis sufferers, they have recently been linked with a

couple of serious side effects.

A new study conducted by the Mayo Clinic discovered a link between the use of Humira or Remicade and the increased likelihood of developing several kinds of cancer or a serious infection. The study determined that rheumatoid arthritis sufferers taking Humira or Remicade were three times as likely to develop cancer and two times as likely to develop a serious infection.

Previous studies evaluating the safety of Humira and Remicade focused specifically on the drugs' ability to cause lymphoma, pneumonia or tuberculosis. The Mayo Clinic study was able to determine a link between use of the rheumatoid arthritis drugs and the

development of several other cancer types, including skin cancer, gastrointestinal cancer, breast cancer and lung cancer.

Additionally, the Food and Drug Administration has received several reports of cancer –

primarily lymphomas – in patients who began taking the rheumatoid arthritis medications before the age of 18. They are further investigating these claims.

Humira was manufactured by Abbott Laboratories, while Remicade was manufactured by Centocor. Neither drug manufacturer is ready to accept the results of the Mayo Clinic

study, claiming the research is flawed. The manufacturers also claim that even with the

possibility of side effects, the drugs still have a favorable "benefits-to-risks ratio."

The controversy surrounding Humira and Remicade side effects is just beginning as

additional studies are underway to verify the initial findings of the Mayo Clinic study.