Opana ER Removed from U.S. Market
July 6, 2017 – Endo Pharmaceuticals has announced that it will comply with the U.S. FDA’s request to remove Opana® ER (oxymorphone extended release) tablets from the U.S. Market. The company plans a gradual withdrawal, and will work with the FDA and prescribers to assure that Opana ER patients have adequate alternatives to treat their constant, long-term, moderate-to-severe pain.
Although it was re-formulated in 2012 to prevent abuse by inappropriate delivery methods, Opana ER did not receive FDA designation as abuse-deterrent. The product can still be abused by inhalation through the nose, or by injection. Endo maintains confidence that Opana ER is safe and effective when used appropriately.
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.