FDA Advisers: Opana's Benefits Don't Outweigh Its Risks — Physician’s First Watch
FDA Advisers: Opana's Benefits Don't Outweigh Its Risks
By Amy Orciari Herman
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.