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FDA Takes A Stand Against Opana

Opana ER label

This ruling could lead to changes in labeling, prescribing or even a ban.

Two federal advisory panels have ruled overwhelmingly that the risks far outweigh the benefits of a new formulation of the drug Opana. This will hopefully lead to a ban or, at minimum, stricter regulations by the Federal Drug Administration (FDA). Two different panels voted 18-8 that this drug is far more risky than beneficial. Many feel that with its new extended release formulation, that is suppose to cut down on the likelihood of abuse, it may be more dangerous than the original version.

This decision by the advisory panel could lead to anything from a ban on Opana to lesser adjustments such as how it is labeled or prescribed. In 2012, Opana passed Oxycontin as the most abused prescription pain pill according to reports.

“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 terrorized the country. It has been tied to numerous health issues, including a rare blood clotting problem that plagues those who abuse it. Opana was also connected to a HIV outbreak in Southern Indiana in 2015. This outbreak was so severe it caused the Governor at the time to declare a public health emergency.

The new formulation was created to try and stop users from crushing the pill and snorting it but unfortunately led people to start injecting the drug. When injected, Opana can be ten 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.

A recent study by The Center for Disease Control and Prevention (CDC) found that the new extended release formulation caused more harm than the previous version. This new formulation caused users to inject multiple times a day due to withdrawal symptoms kicking in quicker than with the old version of Opana.

Many feel that the term ‘abuse deterrent’ that Opana manufacturer Endo Pharmaceuticals uses to describe the new formulation is incredibly misleading. “Abuse-deterrent forms of opioids still contain similar risks,” says Wen, an emergency medicine doctor who says there is an “epidemic of overprescribing.”

If the drug were instead called “crush resistant,” it would “certainly give doctors a clearer picture,” said Indiana health commissioner Jerome Adams, an anesthesiologist.

This a welcomed step towards helping face some of the reality behind the opioid epidemic that our nation faces. Hopefully, the FDA will take the necessary steps to show the pharmaceutical industry that something must be done. The links below are articles on this same ruling if you wish to read more on this subject.

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