Endo Pharmaceuticals agreed to pull Opana ER, its abuse-deterrent , extended-release formulation of the powerful painkiller oxymorphone, off the market after urging by the Food and Drug Administration (FDA) to stop selling the drug because it not only aggravated the opioid epidemic, it also put abusers at risk of serious health problems.
Endo obliged reluctantly, saying it “continues to believe in the safety, efficacy and favorable benefit-risk profile” of the drug. “Nevertheless, after careful consideration and consultation with the FDA following the FDA’s June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”
The FDA made the request last month after a review of marketing data that showed a significant shift in the abuse of Opana ER from being snorted to being injected after the company reformulated the painkiller to resist crushing. The data also showed that injection abuse with the reformulated Opana ER was contributing to an outbreak of HIV infection and hepatitis C virus infection, as well as cases of thrombotic microangiopathy, a serious blood disorder.
This marks the first time the agency has requested the removal of a marketed opioid from the market because of the public health consequences of abuse.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said. “This action will protect the public from further potential for misuse and abuse of this product.”