Accutane Pulled Off the Market after Jury Verdict
Roche Holding AG, one of biggest makers of cancer drugs, pulled its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease. Roche notified the FDA today that it would be withdrawing Accutane after a reevaluation of the product showed it faced serious challenges from generic competitors, company officials stated.
About 13 million people have used Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.
The company faces as many as 5,000 personal injury claims over Accutane, said Michael Hook, a Pensacola, Florida based attorney, who won a $10.5 million verdict against the drug maker over the medicine in April 2008. “We’ve been winning the cases with the drug still on the market, but this move certainly isn’t going to hurt us going forward”, Hook said in an interview today.
Use of Accutane has been linked to birth defects and depression. Users allege that the drug maker failed to properly warn that the medicine could cause inflammatory bowel disease.
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