Pharmacy Services Alerts
Oxymorphone hydrochloride (Opana ER) - Request to Remove from Market
Jun 15, 2017 11:42 AM
FDA requested Endo Pharmaceuticals voluntarily stop marketing oxymorphone hydrochloride (Opana ER) due to increased abuse of the product. In March 2017, an FDA advisory committee concluded the risks of oxymorphone ER now outweigh the benefits of use. Oxymorphone ER was originally approved in 2006 to treat moderate-to-severe pain on a long-term basis. Reformulation of the product in 2012 was intended to prevent abuse by nasal and injectable routes. However, abuse continues to occur. Thrombotic microangiopathy and outbreaks of hepatitis C and HIV have been reported as a result of abusing oxymorphone ER.
FDA will formally withdraw approval of oxymorphone ER if Endo Pharmaceuticals does not remove the product voluntarily. Until the company responds, the FDA is warning about the significant abuse potential of reformulated oxymorphone ER. The risks and benefits of other opioid analgesics continue to be evaluated, and actions will be taken as necessary to reduce opioid abuse and misuse.
- FDA New Release, June 8, 2017