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FDA Requests Removal of Opana ER From Market

FRIDAY, June 9, 2017 -- Sales of reformulated Opana ER should be halted in the United States, the U.S. Food and Drug Administration says.

The FDA first approved Opana ER in 2006 for the management of moderate-to-severe pain in patients who needed an around-the-clock opioid over an extended period of time. In 2012, the drug's manufacturer, Endo Pharmaceuticals, replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to abuse.

The FDA reports that reformulated Opana ER has been linked to HIV and hepatitis C outbreaks, as well as cases of thrombotic microangiopathy. In March 2017, an FDA advisory committee concluded that the benefits of reformulated Opana ER no longer outweigh its risks.

If Endo does not voluntarily remove reformulated Opana ER from the market, the FDA said it would withdraw approval of the drug. Until Opana ER is taken off the market, the FDA is warning health care professionals and others of the serious risks associated with abuse of the drug.

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Posted: June 2017

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