Malvern Pharma Co. Asked To Pull Opioid Painkiller

MALVERN, PA – The Food and Drug Administration has asked a Malvern pharmaceutical company to pull one of its products from the market as concerns about opioids rises across the country. This marks the FDA's first effort ever to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse, according to the FDA.

The FDA asked Endo Pharmaceuticals to remove an extended-release opioid painkiller from the market "based on its concern that the benefits of the drug may no longer outweigh its risks."

"We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse," FDA Commissioner Scott Gottlieb, M.D. said in a statement. "We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."

The drug in question is Opana ER.

After reviewing postmarketing data that showed a "significant shift in the route of abuse of Opana ER from nasal to injection," the FDA made the request Thursday, June 8.

"Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy)," the FDA said in a press release. "This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks."

Philly.com reports Endo is reviewing the FDA's request and is weighing its options moving forward.

Endo told the outlet that more than half the panel members “expressed their preference that Opana ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse.”

If Endo opts not to pull the drug, the FDA said it will take steps to require it be stricken from the market by withdrawing its approval, which was granted in 2006 and again in 2012 when the drug was reformulated, accordion to the FDA.

"In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product," the statement reads.

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