In the alert, Health Canada said a review of the Roche global safety database found that as of November 22, 2009, 66 cases of severe skin reactions including SJS and TEN, in adults and children have been reported worldwide in association with Accutane side effects. Since two of the cases were fatal, everyone who associates his/her health problems with taking this drug should contact his/her doctor immediately and may start thinking to initiate an Accutane lawsuit in Canada or elsewhere to get both moral and financial compensation.

People taking Accutane have been advised to stop taking the medication immediately and contact their doctor if they experience any of the following:

• rash, especially if associated with fever and/or malaise or conjunctivitis (red or inflamed eyes, like “pink eye”)

• blisters on legs, arms or face and/or sores in mouth, throat, nose or eyes

• peeling skin

Health Canada said the Canadian Product Monograph for Accutane will be updated to reflect this new safety information.

Roche said Accutane will be pulled in the U.S. and 11 other countries. The last date for distribution in the United States was June 25. According to Reuters, Accutane is now no longer available from Roche directly but patients may still be able to get it from pharmacies.

According to Bloomberg.com, the company said a reevaluation of its product line had shown Accutane faced serious competition from generics.  In announcing its decision to pull Accutane, Roche also cited the high cost of product liability suits – it currently faces 5000 such lawsuits – involving the drug.  Accutuane lawsuits have resulted in damage awards to plaintiffs totaling $33 million, Bloomberg said.

Most recently, Roche lost several Accutane lawsuits brought by people who claimed the drug caused them to develop inflammatory bowel disease (IBD) as one of the numerous Accutane side effects. In  November 2008, a New Jersey jury ordered the company to pay $13 million to three such plaintiffs.  The previous April, another New Jersey jury awarded $10.5 million to a woman who blamed the drug for her ulcerative colitis. In May 2007, another New Jersey trial  resulted in an  award of $2.62 million to a patient who needed to have his colon and most of his rectum removed after taking the drug.  In October that  same year, a Florida jury  awarded $7 million in damages to another Accutane user who developed the IBD.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the United States.  Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. Besides,the drug’s side effects were studied thoroughly in Canada. The researchers investigated the links between Accutane and severe, possibly fatal skin reactions, including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. The fact caused a flurry of Accutane lawsuits in Canada.

The jury awarded a total of $12.9 million to the three plaintiffs, all of whom were from Florida.  According to Bloomberg, Jordan Speisman, 27, won compensatory damages of $8.5 million and medical expenses of $142,500; Lance Sager, 28, damages of $2.5 million and medical costs of $125,000; and Kelly Mace, 25, damages of $1.5 million and medical expenses of $128,000.

This is the fourth time Roche has lost an Accutane trial involving IBD.  In April, we reported that another New Jersey jury awarded $10.5 million to a woman who blamed the drug for her ulcerative colitis. In May 2007, another New Jersey trial  resulted in an  award of $2.62 million to a patient who needed to have his colon and most of his rectum removed after taking the drug.  In October that  same year, a Florida jury  awarded $7 million in damages to another Accutane lawsuit plaintiff who developed the IBD.

Since being approved in 1982,  Accutane has been controversial because of its association with various serious side effects. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to 266 cases of suicide in the United States.  In addition to IBD, Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.  Because of these problems, Accutane has been named in over 500 lawsuits.

Celebrex and Bextra are COX-2 inhibitors, a class of drugs that also includes Merck’s recalled Vioxx.  Such medications are linked to an increased risk of blood clots, heart attacks and strokes. In 2004, the Food and Drug Administration’s (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Last November, Merck announced a $4.85 billion settlement with the thousands of people who had filed Vioxx injury lawsuits.  Under the terms of the settlement, Merck set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. Partial settlement payments started going out to some Vioxx plaintiffs last month.

Pfizer withdrew Bextra from the market in 2005, and  Celebrex is the only COX-2 inhibitor still on the market in the United States. Celebrex carries the FDA’s strictest “black-box” warning on its drug label, stating that it may cause an increased risk of serious cardiovascular events such as heart attacks and strokes.

Pfizer said it hopes to finalize the settlement by the end of the year.  A spokesperson for the company said that Pfizer would also like to include many of the remaining personal injury lawsuits the settlement.  The company will fight those not settled with court motions or at trial.

According to The New York Times, $760 million of the Bextra and Celebrex settlement would go to settle roughly 7,000  personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs.

In an interview with The Wall Street Journal, Russell Katz, director the FDA’s neuropharmacological drug division confirmed the suicide warnings are coming. “We are working on the labeling changes that we want to get to the companies,” he said. An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide on July 10, but the Journal speculated the new warnings could come even sooner than that.

In addition to treating epilepsy, the anti-seizure medications are used for a variety of other illnesses, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide. The 11 epilepsy drugs slated for a new suicide warning are:

• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
• Zonisamide (marketed as Zonegran)

According to the January early communication, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

At least one drug maker, Pfizer Inc., is less than pleased at this development. Pfizer disputed the FDA’s analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York. Pfizer especially disputes the inclusion of Lyrica – one of the company’s biggest growth drivers -on the FDA’s warning list. Pfizer said that Lyrica accounted for only 6.3% of the total 142 suicidal events cited by the FDA analysis. But the FDA is sticking to its guns, and the new suicide warning will apply to all 11 epilepsy drugs.

A woman who blames Accutane for the ulcerative colitis that caused her to have her colon removed has been awarded $10.5 million in an Accutane lawsuit. The lawsuit, filed by a personal injury law firm in New Jersey, was the third Accutane case involving inflammatory bowel disease to come to trial, all of which have resulted in favorable verdicts for Accutane paintiffs. Hoffman-LaRoche, the maker of Accutane, has said it will appeal all of the verdicts, and insisted that the link between Accutane and inflammatory bowel disease has not yet been proven. In a statement, the company also said that “the Accutane labeling has contained a warning about IBD for more than 20 years.”

According to the Wall Street Journal, Kamie Kendall, a 24-year-old Utah hairdresser, started taking Accutane at age 12. She was diagnosed with ulcerative colitis at the age of 14, and in 2006 she had her colon removed and now suffers from debilitating diarrhea. The jury awarded Kendall $10.5 million of compensatory damages plus $78,500 for medical expenses. The judge presiding over the case ruled there was insufficient evidence to allow the jury to consider punitive damages or consumer fraud.Kendall is the third Accutane plaintiff to successfully sue Hoffman-LaRoche over inflammatory bowel disease. In May, another New Jersey jury awarded $2.62 million in damages to a patient who needed to have his colon and most of his rectum removed after taking the drug Accutane. In October, A Florida jury awarded $7 million in damages to another Accutane user who developed the disorder and said Hoffman-LaRoche failed to adequately warn of the drug’s risks.

Inflammatory bowel disease refers to two chronic diseases that cause inflammation of the intestines: ulcerative colitis and Crohn’s disease. In ulcerative colitis, the inner lining of the intestine becomes inflamed and develops ulcers. Ulcerative colitis is often the most severe in the rectal area, which can cause frequent diarrhea. Mucus and blood often appear in the stool if the lining of the colon is damaged. Everyone who ever suffered these health problems associated with LaRoche’s drugs still can easily file either Accutane Crohn’s lawsuit or ulcerative colitis lawsuit in order to get a financial and moral compensation.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. In addition to inflammatory bowel disease, the drug has been associated with myriad other serious side effects. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to 266 cases of suicide in the United States. In addition to inflammatory bowel disease, Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. Canadian researchers have also discovered a link between the drug and severe skin reactions. Almost every Accutane lawsuit in Canada states that the plaintiff suffered these adverse effects.

But last summer, the Food and Drug Administration (FDA) heard evidence that iPledge has not ended the problem.  There were 122 pregnancies in the program’s first year and another 37 in the four months since.  Another 19 pregnancies occurred in women who managed to get the drug despite never enrolling in iPledge.  Despite this, in October, the FDA agreed to a few changes, announcing Wednesday that iPledge is now implementing these changes.  Women of childbearing age who do not fill a prescription within seven days of a pregnancy test will be allowed to get another test and then fill the prescription, with the exception of the initial prescription.  Until now, those who didn’t act within seven days were frozen out of the program for the next 23 days.  Those women will have to fill the prescription within seven days of a pregnancy test rather than within seven days of first seeing their doctor.

Accutane is considered the biggest breakthrough in acne drug therapy in the past two decades and is the only drug with the potential to clear acne permanently after once course of treatment, which is usually five months.  Accutane should be reserved for cases of severe recalcitrant nodular acne, the type of acne resistant to standard acne treatment, including oral antibiotics, and is characterized by many nodules or cysts-inflammatory lesions filled with pus and lodged deep within the skin. The lesions can cause pain, permanent scarring, and negative psychological effects.

Since the FDA approved Accutane in 1982, nearly 5 million people in the U.S. and 12 million worldwide have been treated with it.  Half the patients taking the drug are females, most of childbearing age.  Accutane is known to be teratogenic, or able to cause birth defects, and is designated Category X, meaning it must be avoided under all circumstances during pregnancy.  Nursing mothers also should not use the drug.  Accutane birth defects risk among pregnant women is extremely high-25 to 35 percent-and include hydrocephaly (enlargement of the brain’s fluid-filled spaces) and microcephaly (small head), heart defects, facial deformities such as cleft lip and missing ears, and mental retardation.  This does not account for other defects not detectable at birth, such as learning disabilities.  Also, patients may develop serious problems affecting organs such as the liver, intestines, eyes, ears, and skeletal system.  Some patients have developed serious psychiatric problems, including Accutane depression; some have developed suicidal behavior and others have succeeded in their suicide attempts.