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FDA Requests Drug That Helped Spark HIV Outbreak Be Pulled

For the first time ever, the U.S. Food and Drug Administration is asking a pharmaceutical company to remove an opioid from the market due to the dangers of abuse. The drug is linked to Indiana's HIV outbreak.

The FDA wants Endo Pharmaceuticals to voluntarily remove  the reformulated Opana ER from the market. The company reformulated the opioid in 2012 to make it harder for people to crush and snort or inject, but people found another way to abuse Opana. Heating the pills melts the coating, allowing people to inject the drug. It was popular in Scott County, where the sharing of dirty needles sparked an HIV outbreak.

The FDA's request comes after the agency reviewed all data available about the use of Opana ER, which revealed significant abuse after the drug's reformulation. Deputy Director for Regulatory Programs at the FDA's Center for Drug Evaluation and Research Dr. Douglas Throckmorton says data revealed people were injecting the reformulated version of Opana more than other, similar opioids.

"That intravenous abuse is so damaging, so dangerous that unless there are other benefits to offset we need to find ways to either prevent it or, in this case, request that the product no longer be on the market," Throckmorton says.

Endo Pharmaceuticals says it's reviewing the FDA's request and weighing its options.

"While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S.," the company says in a statement. "As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo 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."

"They're just going to switch to something else."

Even if the company does agree to take Opana off the market, Scott County's public health nurse says she doesn't expect it to have an impact on her community.

"They're not just going to quit using because Opana's taken off the market," Combs says. "They're just going to switch to something else."

She says the focus needs to be on increasing addiction and mental health treatment, as well as providing stable housing for those in recovery.

"We pretty much tell them right now you cannot come back to this area if you want to quit and stay quit because there's too many triggers and it's not a safe place for you as an addict to come back to," Combs says.

Throckmorton says the FDA's request is just one part of the equation when it comes to addressing the nation's opioid epidemic.

"There are scientific, social, legal issues that make it very challenging to find one way to address opioid abuse," he says.

In addition to the HIV outbreak, the FDA says abuse of the drug has been linked to cases of a serious blood disorder called thrombotic microangiopathy.

If the company doesn't voluntarily remove Opana ER from the market, the FDA will begin the process to formally require its removal.

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