Opioid Pulled From Market Following FDA Request
After careful consideration and consultation with the US Food and Drug Administration (FDA), Endo Pharmaceuticals will voluntarily remove Opana ER, an abuse-deterrent opioid, from the market.
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Opana ER is indicated for the management of severe pain that requires daily, around-the-clock, long-term opioid treatment after alternative treatment options are found to be ineffective. The FDA requested the removal of this opioid on June 8, 2017, after a review of all existing data showed a shift in the route of abuse of the drug from nasal to injection, and that its abuse through injection was connected with outbreaks of HIV and hepatitis C.
Endo intends to work with the FDA in coordinating the removal of Opana ER to minimize treatment disruption for patients, and provide physicians with enough time to consider alternative options for patients in need of long-term opioid therapy for managing chronic pain.
—Melissa Weiss
Reference:
Endo provides update on OPANA® ER [press release]. Dublin, IE: Endo; July 6, 2017. http://www.endo.com/news-events/press-releases. Accessed July 8, 2017.