After multiple verdicts awarding millions of dollars in damages to sickened patients, Roche is pulling its controversial acne drug Accutane from the U.S. market.
Prescribed for severe acne, often as a last resort, Accutane received FDA approval in 1982. Over the years, it gained a reputation as a high-risk medication with potential side effects such as birth defects, depression and suicide. Most of the lawsuits involved patients who reportedly developed inflammatory bowel disease as a result of Accutane use, their cases underpinned by claims that they were not sufficiently warned of the risk.
Roche, however, says their decision to discontinue American Accutane sales had nothing to do with health hazards.
“Roche stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA,” a spokesperson said in a statement. Instead, they point to the financial impact of generic competition as the key factor.
Accutane had already been pulled from the market in Austria, Denmark, France, Germany, Norway, Portugal and Spain.
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