Endo Pharmaceuticals, Inc. Announces Withdrawal of Opana ER

Released: 07/10/2017   By: Heidi Dufrene, PharmD

Endo Pharmaceuticals announced it would be voluntarily withdrawing Opana ER (Oxymorphone ER) from the market. In June, the FDA requested that Endo remove Opana due to public health concerns regarding abuse of the medication. The FDA stated “after careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.” Abuse of the reformulated Opana ER shifted from nasal use to injection. This shift is associated with an outbreak of HIV and Hepatitis C. The FDA stated that the request to withdraw Opana ER from the market would protect the public from further potential for misuse and abuse.

Endo’s website states that the company “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER when used as intended, and notes that the company has taken significant steps over the years to combat misuse and abuse.” The company states that it plans to work with the FDA for an orderly removal of the opioid in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals. At this time there is no withdrawal date set for the product.

Carlisle Medical will continue to monitor and post any updates regarding the withdrawal of Opana ER on our website.

FDA requests removal of Opana ER for risks related to abuse (news release). July 8, 2017. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm562401.htm. Accessed July 7, 2017.

Endo Provides Update on Opana ER (news release). July 6, 2017. http://www.endo.com/news-events/press-releases. Accessed July 7, 2017.