FDA calls for removal of Opana ER due to abuse risks

Due to concerns that risks related to abuse outweigh the benefits of reformulated Opana ER (oxymorphone hydrochloride) the FDA is requesting that Endo Pharmaceuticals pull the drug from the market, marking the first time the agency has taken action to pull an opioid pain medication from sale because of public health consequences related to abuse, according to a recent press release.

“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,” Scott Gottlieb, MD, FDA Commissioner said in the release. “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.”

Postmarketing data uncovered a significant shift from nasal to injection abuse of Opana ER following its reformulation which has led to a serious outbreak of HIV in Indiana in 2015, as well as outbreaks of hepatitis C, in addition to cases of thrombotic microangiopathy, a serious blood disorder, according to the FDA.

The FDA’s decision follows its advisory panel ruling in March that reformulated Opana ER’s benefits are not as substantial as the risks.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market. This action will protect the public from further potential for misuse and abuse of this product.”

If Endo chooses not to remove reformulated Opana ER from the market voluntarily, the FDA will withdraw its approval and formally require the drug’s removal.

In a statement on its website, Endo said that it was “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.”

Endo noted that the FDA’s request did not reflect concerns with the safety or efficacy of Opana ER when taken as prescribed, but the company “feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products.”

Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.