FDA Advisers: Opana's Benefits Don't Outweigh Its Risks — Physician’s First Watch

Medical News |
March 16, 2017

FDA Advisers: Opana's Benefits Don't Outweigh Its Risks

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

The benefits of the opioid painkiller Opana ER — an extended-release version of oxymorphone — do not outweigh its risks, an FDA advisory panel concluded on Tuesday.

After a new "abuse-deterrent" version of Opana was introduced in 2012, rates of misuse by snorting did decrease — but misuse by injection increased. The rise in injection misuse has been associated with increases in rates of HIV and some blood disorders, the panel noted.

Eighteen of the advisers voted that Opana's risks exceed its benefits, eight voted to the contrary, and one abstained from voting, Reuters reports. The FDA usually follows its panel's recommendations, but it's not obligated to do so.

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