At a two-day joint meeting of the U.S. Food and Drug Administration‘s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSARM), committee members voted 18–8, with one abstention, that the benefits of Opana ER (oxymorphone hydrochloride) do not outweigh its public health risks.1 The health risks include recent HIV and hepatitis C virus (HCV) outbreaks, as well as vascular issues, related to intravenous abuse of this drug. An HIV outbreak in Scott County, Ind., which resulted from needle sharing among patients co-infected with HCV and HIV, has been linked to intravenous Opana use.2
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Opana has a turbulent FDA regulatory history. The treatment was originally approved in 2006 to treat chronic pain. In 2011, the manufacturer, Endo Pharmaceuticals, reformulated the drug to make it harder to abuse. However, the new formulation never won abuse-deterrent labeling from the FDA. The manufacturer was also unable to stop generic versions of its initial formulation from becoming available, despite claiming the new version was safer. After the reformulation, 15 cases of thrombotic thrombocytopenic purpura were reported among injection-drug users who had recently injected reformulated Opana ER. This outbreak occurred in Tennessee in 2012 and was evaluated by and reported on by the Centers for Disease Control and Prevention.3 Additional case reports have been published.4
A number of FDA Advisory Committee members expressed their preference that the drug remain on the market with additional regulatory restrictions to mitigate its risks. Most of the panelists felt that revising and resubmitting the drug’s New Drug Application may resolve these issues. The manufacturer remains committed to reducing the potential abuse, misuse and diversion of its products.5
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Fiore K. FDA joint panel votes down Opana ER: Too many risks with reformulated version tied to HIV, TTP clusters. 2017 Mar 15.
- Centers for Disease Control and Prevention. Community Outbreak of HIV Infection Linked to Injection Drug Use of Oxymorphone—Indiana, 2015. MMWR. 2015 May 1;64(16):443–444.
- Centers for Disease Control and Prevention. Thrombotic thrombocytopenic purpura (TTP)-like illness associated with intravenous Opana ER abuse-Tennessee, 2012. MMWR. 2013 Jan 11;62(01):1–4.
- Miller PJ, Farland AM, Knovich MA, et al. Successful treatment of intravenously abused oral Opana ER-induced thrombotic microangiopathy without plasma exchange. Am J Hematol. 2014 Jul;89(7):695–697. doi: 10.1002/ajh.23720. Epub 2014 Apr 15.
- Endo International Plc. News release: Endo statement on FDA advisory committees’ vote related to Opana ER. 2017 Mar 14.