Opana ER, an opioid pain medication, is being pulled from the market because of abuse after a first-of-its-kind request from the Food and Drug Administration.
One month after the FDA’s request, Endo Pharmaceuticals said it has decided to voluntarily stop selling the powerful drug.
Opana ER pulled from the market at FDA request
“Endo plans to work with FDA to coordinate the orderly removal of Opana ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals,” the company said in a statement.
Despite its decision to remove the drug, Endo said it “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended.”
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 June 2017 request came 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.”