Endo International Plc on Thursday announced that it will voluntarily withdraw its Opana ER opioid painkiller from the U.S. market.
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The announcement came after FDA in June asked Endo to withdraw Opana ER from the market, citing concerns that the drug's benefits might no longer outweigh its associated risks.
FDA said a review of post-marketing data revealed a "significant shift in the [drug's] route of [misuse]" from individuals snorting the drug to them injecting it. According to FDA, the misuse of the drug via injection has been linked to cases of a serious blood disorder, known as thrombotic microangiopathy, as well as an outbreak of HIV and hepatitis C in Indiana in 2015, where individuals shared needles to inject the drug.
Endo said it will work with FDA to remove Opana ER from the U.S. market.
The company in a statement said it "continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER … when used as intended," adding that it "has taken significant steps over the years to combat misuse and abuse" of the drug. However, Endo continued, "after careful consideration and consultation with FDA following FDA's June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market."
According to Bloomberg, FDA did not immediately respond to a request for comment on Endo's announcement (Hopkins, Bloomberg, 7/6; Grover, Reuters, 7/6; Ramsey, Business Insider, 7/6).
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