Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN] and other serious skin reactions have been associated with the use of Accutane, according to a public health alert issued by Health Canada.

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.

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Following  years of controversy and lawsuits, Roche AG has decided to pull Accutane from the market.

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. (more…)

Another jury has found the maker of Accutane liable for inflammatory bowel disease (IBD) in three people, and ordered the drug’s maker to pay the victims nearly $13 million. According to Bloomberg News, a jury in Atlantic City, New Jersey ruled yesterday that Roche AG failed to properly warn of Accutane side effects.

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. (more…)

Pfizer could soon settle at least 90 percent of the personal injury lawsuits it faces over the painkillers Bextra and Celebrex.  The company announced today that it hopes to finalize a $894 million settlement by the end of the year.

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.

A report in The Wall Street Journal confirms that 11 epilepsy drugs will soon have new warnings about suicide. The Food & Drug Administration (FDA) began studying the drug’s potential for suicidality in 2005, and in January the agency issued an Early Communication announcing its review had indicated the epilepsy drugs increased patients’ risk of suicidal thoughts and behavior.

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. (more…)

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. (more…)

Accutane prescriptions might now be a little easier for women to fill.  The government announced some changes Wednesday designed to ease access to the drug.  A program entitled iPledge-a risk management program designed to reduce the risk of fetal exposure to isotetinoin (Accutane) prescribed for the treatment of severe recalcitrant nodular acne-was amended to ensure that every user of Accutane (or its generic substitutes), every doctor who prescribes it, and every pharmacy that sells it follow strict rules ensure sure women do not become pregnant while on the drug.  Among those rules are month-by-month prescriptions based on monthly pregnancy tests.

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.

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