FDA Requests Voluntary Removal of Opana ER from Market
June 8, 2017 – The U.S. FDA has requested that Endo Pharmaceuticals voluntarily withdraw Opana® ER (oxymorphone extended release) from sale on the American market. The FDA made the formal request for voluntary removal based on post-marketing data and recommendations made by the FDA’s Advisory Committees on Drug Safety/Risk Management and Anesthetic/Analgesic Drug Products. The FDA maintains that the value of the drug in treating chronic major pain no longer balances its risk of being abused.
Although Opana ER was reformulated in 2011 to make abuse of the drug by crushing and inhaling it more difficult, the new formulation remained subject to abuse by injection. Abuse of Opana ER by injection has been implicated in the spread of HIV and hepatitis C among users who share contaminated syringes and needles. Endo has stated that it is considering its options, saying that the majority of advisory committee members suggested more strict regulation of Opana ER, rather than removal from the market, and that the FDA notice does not specifically question Opana ER’s safety when used as prescribed. However, the FDA has stated that it is prepared to rescind the drug’s approval if its sale is not discontinued.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.