For the first time ever, the Food and Drug Administration is requesting that a drug company stop selling an opioid pain medication because of abuse.
The FDA said Endo Pharmaceuticals must pull Opana ER, oxymorphone hydrochloride, from the market.
FDA to drugmaker: Pull Opana ER from the market
After Opana ER was reformulated in 2012, the FDA said abusers began injecting it more than snorting it. Injection abuse of the drug has been associated with an outbreak of HIV and hepatitis C, as well as a serious blood disorder.
The FDA’s decision comes after a group of independent experts met in March and voted 18-8 that the benefits of reformulated Opana ER no longer outweigh the risks.
“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
Opana ER was initially approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Its reformulation in 2012 was intended to make the drug resistant to manipulation for 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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”
If Endo Pharmaceuticals doesn’t comply with the FDA’s request, the agency said it will take steps to formally require its removal by withdrawing approval.
In a statement, Endo said it’s reviewing the request and “evaluating the full range of potential options.”