The drug was not withdrawn for not working, more so due to lawsuits and side effects, depression for one. As noted below, the US is not the first market to have the product withdrawn. Perhaps Acne will be treated more with medical devices such as this one in the future that was approved by the FDA.
Acne problems have also been a bone of contention at times with underwriting insurance in some cases.
Health risks with prescription drugs are important to know about as the complexity of the drugs we take today is increasing. BD
June 26 (Bloomberg) -- Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling 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 U.S. Food and Drug Administration today 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.
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.
Rosenstock said Accutane’s safety wasn’t a factor in the decision to yank it off 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.
In November, a state-court jury in New Jersey found company officials didn’t properly warn doctors about Accutane’s health risks and awarded three men a total of $12.9 million in damages.