Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On July 6, after careful consideration, Endo Pharmaceuticals announced that it will follow the June 2017 FDA ruling and will voluntarily withdraw Opana ER from the U.S. market.2
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The company will work with the FDA to coordinate the organized removal of Opana ER from the market to minimize treatment disruption for patients, enabling patients to receive sufficient guidance from their healthcare providers about alternate pain management. Patients taking Opana ER should discuss treatment options with their physician, and prescribers should contact patients to discuss alternative treatment options.
Endo International continues to believe in the favorable benefit–risk profile of Opana ER for managing severe pain in appropriate patients—those who require a daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. Endo International also remains confident in the clinical research and data demonstrating the treatment’s safety and efficacy.
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.
- U.S. Food and Drug Administration. FDA News Release: FDA requests removal of Opana ER for risks related to abuse. 2017 Jun 8.
- Endo International Plc. News release: Endo provides update on Opana ER. PR Newswire. 2017 Jul 6.