Pharmacy Company Agrees to Take Opioid Painkiller Linked to HIV Outbreak off Market
The FDA requested that the drug be removed in June 2017
Pharmacy Company Endo International has agreed to take the opioid painkiller Opana ER off the market.
Reformulation and Continued Abuse
The U.S. Food and Drug Administration (FDA) requested that the drug be removed in June 2017. The company intends to work with the FDA to coordinate the removal process in such a way that patients will experience minimal disruption in their treatment and will have enough time to ask their healthcare providers for guidance. Those taking Opana should talk about different options with their doctor at their next visit.
Endo does not believe that Opana is unsafe or ineffective as long as it is taken as prescribed. Although the company had reformulated the product in order to make it harder to abuse in the midst of the current nationwide opioid epidemic, the FDA found that users switched from nasal application to injection in order to continue abusing the drug. This led to an outbreak of serious diseases.
"Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy)," stated the FDA.
"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," said Janet Woodcock, M.D., who directs the agency's Center for Drug Evaluation and Research. "This action will protect the public from further potential for misuse and abuse of this product."