Accutane Recall in U.S.

Federal regulators have determined that an Accutane recall issued last year was not due to safety problems with the acne, despite mounting concerns about serious and debilitating cases of inflammatory bowel disease among users.

The FDA issued a notice in the Federal Register, announcing that it has found that neither safety nor effectiveness were the reason for Accutane’s withdrawal from the market last year. However, the acne drug was voluntarily removed by Roche amid mounting Accutane lawsuits alleging that side effects of the drug increase the risk of inflammatory bowel disease, Crohn’s disease, ulcerative colitis and other serious problems.

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