Accutane Recall

Roche notified the U.S. Food and Drug Administration (FDA) that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.  “In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.

About 13 million people have taken 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 drug also has been pulled off the market in 11 other countries including France, Denmark, Austria, Germany, Portugal, Norway and Spain, Rosenstock said. She couldn’t provide dates for those withdrawals. Roche spokesperson said that Accutane’s safety wasn’t a factor in the decision to take the product out of the U.S. market.  “Roche stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA,” she said in the statement.