A drug maker to take this opioid off the market

The United States is in the middle of an opioid crisis, so it’s easy to assume that all opioids can be equally detrimental to people’s health. But now, the Food and Drug Administration says one in particular is especially contributing to the opioid epidemic.

The FDA has asked Irish pharmaceutical company Endo International to take one of its pain medications, Opana ER (oxymorphone hydrochloride), off the market because of its potential for abuse. “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks,” the FDA said in a press release. “This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”

The FDA says its decision is based on a review of data that shows a “significant shift” in the abuse of Opana ER, with more people moving from crushing and snorting the drug to injecting it after the product was reformulated. (Opana ER was first approved by the FDA in 2006, but the reformulated version, which was intended to lower the potential for abuse, was released in 2012.) Now, the FDA says that injections of the new version of Opana ER have been linked with an outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy, a serious blood disorder.

Endo International said in a press release on its website that the company is “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.” The company also said that “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.”

Opana ER is an opioid that is intended to help manage pain that is severe enough to require daily, around-the-clock, long-term treatment.