FDA Calls For Painkiller Opana ER To Be Taken Off The Market

By Paul Gaita 06/13/17

The FDA believes that Opana's potential for misuse outweighs the opioid's benefits.

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In an unprecedented move, the U.S. Food and Drug Administration (FDA) has requested that a major pharmaceutical company remove one of its pain medications from the market due to its abuse as part of the nationwide opioid epidemic.

The agency issued a statement on June 8 that requested that Endo Pharmaceuticals take reformulated Opana ER (oxymorphone hydrochloride) off the retail market due to concerns over rising abuse of the drug through injection, as well as its association with outbreaks of HIV and hepatitis C.

This is the first such request by the FDA to remove a currently marketed opioid pain medication from sale due to public health concerns. Should the drug manufacturer refuse to remove the item from the market, the FDA will revoke its approval.

Opana ER, which was initially approved in 2006 for continuous and extended management of moderate-to-severe pain, was revised in 2012 with a new formulation that was intended to prevent the drug from being abused through snorting or injecting. Though it met the regulatory standards for approval, data suggested that the drug could not be expected to reduce abuse through those means, and the FDA declined the company's request to label the drug as having abuse-deterrent properties. 

Subsequent reviews of Opana ER showed a significant uptick in abuse from nasal to injection, even after the product was reformulated. "[Users] were injecting those materials that were added to try to make it more abuse-deterrent," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

In addition to the increase in abuse, the drug was linked to outbreaks of HIV and hepatitis C, as well as thrombotic microangiopathy, a serious blood disorder. In March 2017, an FDA advisory panel of independent experts voted 18-8 that the benefits of the drug no longer outweighed the risks, which prompted the FDA to issue its request to Endo.

The manufacturer issued a response to the FDA, in which Endo noted that it was "reviewing the request and is evaluating the full range of potential options as [it determines] the appropriate path forward." The company added, "Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed."

If the company does not comply with the FDA's request, Woodcock says the agency will pursue the case. "We ask companies to voluntarily pull their drug off the market," she said. "If they are not willing to do that, we will issue a notice of a hearing, and we have to go through a judicial type of process."

That process may conclude with the FDA withdrawing its approval of the product, which would then require the company to remove Opana ER from shelves.

"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, in the FDA's June 8 statement. "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."

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.