Dangers Of Opana Opioid Painkiller Outweigh Benefits, FDA Panel Says

An advisory panel convened by the Food and Drug Administration to evaluate the health risks of the powerful opioid painkiller Opana ER says that the danger it poses as a drug of abuse outweighs its benefits as a prescription painkiller.

The time-release opioid was reformulated in 2012 to make it harder to crush. The goal was to reduce abuse by snorting it. But users quickly figured out that the new formulation could be dissolved and injected.

Injected Opana ER has been linked to an HIV outbreak in rural Scott County, Indiana in 2015, caused by opioid abusers sharing needles.

NPR's Kelly McEvers and I reported on the abuse of Opana ER in Scott County for the NPR podcast Embedded.

People abusing opioids there told us that it was only after the drug was reformulated that people started injecting it. "The pharmaceutical company, they changed it so you can't crush them and snort them," said Devin. "Whenever they done that, that's when everybody started shooting them."

(Devin is HIV positive, and NPR is withholding his name to protect his privacy.)

Dr. Jerome Adams, Indiana's state health commissioner, spoke to the Food and Drug Administration advisory committee considering the safety of Opana on Monday. He said that there are now 215 cases of HIV in the area, and nearly all of those people had injected Opana.

"I would respectfully suggest that we're here today not so much to look back at what happened," said Adams, "but to make sure it doesn't happen in another community."

Adams said that Opana ER was being overprescribed in the area, and told the committee, "You need to ask yourself, 'Are you helping more people than you're hurting?' "

Data reviewed by the FDA suggest that Scott County is not the only area that saw the shift in abuse to injection. FDA researchers concluded "the reformulation caused a marked shift in the route by which the drug is abused, from nasal to injection."

The FDA's materials include survey data of people entering drug treatment. Among people who reported abusing Opana, the percentage of people who said they injected it roughly doubled after the reformulation, from 17 percent to 38 percent.

Abuse of Opana by injection is especially concerning, because it's been associated with a rare blood disorder known as thrombotic thrombocytopenic purpura, as well as infections of HIV and Hepatitis C.

While Endo, the pharmaceutical company that makes Opana, said the 2012 reformulation was a well-intentioned effort to stop people from abusing the drug, they also had financial interests at stake.

As we reported, the company used the reformulation to try to block generic competition, and said if generic versions of Opana entered the market, "annualized net sales will decrease by an amount up to $135 million."

This week, the advisory committee voted "no" 18 to 8 with one abstention on the question "Do the benefits of reformulated Opana ER continue to outweigh its risks?" It was made up of doctors, researchers and academics.

"It seems clear that the abuse-deterrent characteristics of the product have resulted in unintended consequences," said Jane Acri, chief of the medications discovery and toxicology branch at the National Institute on Drug Abuse. Acri also pointed out that "This is just one of several opioids available for the treatment of chronic pain," so patients would have alternatives.

Several of those voting specifically advocated removing Opana ER from the market.

The eight dissenting committee members worried that such a move would not put a dent in the country's opioid epidemic, because patients would just move to other opioids like heroin or fentanyl. And, they said, it could remove a useful medication from the market.

"Does it have risks? Clearly it does," said David Craig, a clinical pharmacy specialist at the Lee Moffitt Cancer Center & Research Institute in Tampa, Fla. "But for the patients that are taking it appropriately, I think that there is a role for Opana ER in those particular patients."

In a statement posted to their website, the drugmaker Endo said, "Endo believes that Opana ER remains an important clinical choice for appropriate patients and will evaluate the range of available options for maintaining access for legitimate use."

The panel's vote is not binding, but the FDA typically gives deference to its advisory committees. The agency will have to make its own decision about whether to remove Opana from the market, change its labeling, take some other action, or leave it on the market as is.

A spokesperson for the FDA said the agency could not comment on the timeline for any action on the drug.

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