Opana ER Painkillers To Be Pulled From Drug Market

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Opana ER Painkillers To Be Pulled From Drug Market

One month after the U.S. Food and Drug Administration asked Endo International to remove Opana ER from the drug market due to safety risks and potential for abuse, the company has voluntarily agreed to do so. If they had not, the FDA had promised to take actions against them.

Opana ER is Endo International’s brand name for extended release oxymorphone, an opioid painkiller indicated for moderate to severe pain. Endo issued a statement saying that the company continues to believe in the safety and effectiveness of the product and that they have previously taken steps to combat abuse:

“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed.”

Had Endo International not agreed to pull Opana, the FDA said they would have withdrawn approval for the drug, leaving the company with little choice. Endo also noted that it would collaborate with the FDA to remove Opana “in a manner that looks to minimize treatment disruption for patients” and to give time to patients for seeking alternatives.

This action is the first the agency has taken to have a prescription painkiller removed from the market. In 2012, Opana was reformulated in an attempt to make it more difficult to abuse (i.e. by crushing and snorting) but users soon found they could get around it. According to the FDA, Opana has been associated with HIV, hepatitis C, and other diseases spread through dirty needles.

The FDA will meet next week to examine the effectiveness of other opioids with abuse-deterrent formulas, which purport to make pills more difficult for users to crush for snorting or injecting.

Scott Gottlieb, FDA commission has indicated that the agency may take similar actions to have other opioids removed from the market:

“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.”

~ G. Nathalee Serrels, M.A., Psychology

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