FDA Requests First-Ever Removal of Painkiller from Market

Opana ER may be the first of many opioids to have approval revoked.

For the first time, the US Food and Drug Administration (FDA) has requested that a pharmaceutical company remove an opioid pain medication from the market due to the public health consequences of its abuse.

Endo Pharmaceuticals’ oxymorphone hydrochloride (Opana ER) is the subject of the removal request. If the company refuses to voluntarily withdraw the drug from the market, the FDA “intends to take steps to formally require its removal by withdrawing approval,” according to an agency statement.

The decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated oxymorphone hydrochloride no longer outweigh its 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 recently appointed FDA Commissioner Scott Gottlieb, MD. “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.”

FDA data showed that before oxymorphone hydrochloride was reformulated in 2012, people commonly abused it via nasal ingestion. After its reformulation, people began abusing it via subcutaneous injections. Injection abuse was associated with serious outbreaks of HIV and hepatitis C, as well as cases of thrombotic microangiopathy, a serious blood disorder.

“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, MD, 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.”

Other opioid pain medications may be under consideration for requests for removal as well, because, according to the agency statement, “the FDA will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”

Oxymorphone hydrochloride was first 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. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for the drug.