Opana Risks Outweigh Benefits, Says FDA Panels

By Kelly Burch 03/17/17
This could lead to changes in labeling, prescribing or even a ban.
White pills.

Two federal advisory panels have determined that the risks outweigh the benefits of a new formulation of the drug Opana—which could lead to a ban or tighter regulations on the drug by the Food and Drug Administration (FDA). 

Two FDA panels voted 18-8 that the pill presents more dangers than benefits. One advocacy group even claims that its new formulation, an extended-release pill that was supposed to cut down on the likelihood of abuse, may actually be more dangerous than the original, according to reports in USA Today

The advisory panels' decisions could lead to a ban on Opana, or lesser changes like adjustments to how the pill is labeled and prescribed. 

In 2012, it was reported that Opana had bypassed OxyContin as the most abused prescription pain pill in the country. 

"When OxyContin changed, the drug abusers looked for a different thing. Opana emerged immediately," Sgt. Jerry Goodin of the Indiana State Police said at the time. "Seems like every time we get a handle on something, another evil pops its head up.”

Since then, Opana has been associated with a number of health issues, including a rare blood-clotting problem among people who abuse the drug. In 2015, the drug was connected with an outbreak of HIV in Indiana. The rate of new infections was so steep that the governor declared a public health emergency. 

The new formulation was designed to prevent drug abusers from snorting the pills, but it instead led to people injecting the drug. When it is injected, the drug is 10 times more powerful than morphine. 

"This characteristic makes the drug especially desirable and especially dangerous to opioid-addicted injection drug users," Andrew Kolodny, the executive director of Physicians for Responsible Opioid Prescribing, told USA Today

Although the pill was reconfigured to make it harder to crush, that does not prevent abuse, Kolodny said. 

In fact, a Centers for Disease Control and Prevention (CDC) study found that the extended-release formula of Opana was linked to addicts injecting multiple times a day because withdrawal symptoms would appear sooner than with the original version of the pill. 

Representatives from the drug manufacturer Endo Pharmaceuticals testified that Opana is not more harmful than any other opioid. “All opioids, including oxymorphone, are abused,” said Harris Rotman, vice president of regulatory affairs at Endo.

However, Indiana Health Commissioner Jerome Adams testified that Opana has accelerated drug addiction in his state. 

Emily Walden, whose son died of an Opana overdose, hopes the FDA will enact a total ban on the drug. “You can put a coating around it and pretend it is safer and people will still become addicted and people are still going to die,” she said. 

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.