Manufacturer Removes Opana ER From Market
Endo International plc, the manufacturer of an extended release formulation of oxycodone known as Opana ER, announced July 6 that it was voluntarily complying with a request from the U.S. Food and Drug Administration (FDA) to remove its product from the pharmaceutical market. The FDA stated in a recent press release that the benefits of using Opana ER as intended to manage pain no longer outweigh the risks regarding its potential for misuse and abuse.
Endo developed Opana ER for round-the-clock management of severe pain for which alternate treatments have been ineffective. The drug was first approved in 2006. Responding to concerns about drug abuse by crushing and snorting the pills, the original product formulation was changed in 2012 to try to reduce its potential for abuse. The new formulation was developed with the intention of making the drug resistant to abuse by nasal inhalation or injection. This new formulation met the regulatory standards for approval, but the FDA’s recent review of postmarketing data shows rising public health concerns associated with the new Opana ER. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C among people who inject the drug with shared needles, as well as cases of thrombotic microangiopathy, a serious blood disorder.
No harm has been reported when the drug is used as prescribed for appropriate patients. In its July 6 announcement, Endo declared that it will coordinate with the FDA to remove Opana ER with as little disruption to patient treatment as possible. Patients taking Opana ER should discuss treatment options with their prescribing physician at their next visit.
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