FDA Requests Voluntary Removal of Opioid
For the first time, the US Food and Drug Administration (FDA) has requested that the opioid medication Opana ER (oxymorphone hydrochloride) be removed from the market due to public health concerns.
The decision to request the removal of the drug was based on a review of all available postmarketing data that showed a significant shift in the route of abuse from nasal to injection of the drug after it was reformulated in 2012 in an attempt to reduce the physical or chemical manipulation of Opana ER for nasal or injection use. In addition, the injection abuse of Opana ER has been associated with outbreaks of HIV and hepatitis C, and serious cases of thrombotic microangiopathy. An advisory committee that meet in March of this year voted 18 to 8 to remove the drug as the benefits no longer outweighed the risks associated with the product.
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The FDA has asked Endo Pharmaceuticals to remove Opana ER voluntarily and intends to take steps to formally require the drug’s withdrawal if the company chooses not to remove the drug.
In an effort to reduce the public health burden of the opioid crisis, the FDA will continue to examine the risks and benefits of all approved opioid analgesic drugs on the market.
FDA requests removal of Opana ER for risks related to abuse [press release]. FDA. Published June 8, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed June 9, 2017.