Tags: fda | panel | opana er | risks | benefits

FDA Panel: Opana ER Painkiller Poses More Risks Than Benefits

Image: FDA Panel: Opana ER Painkiller Poses More Risks Than Benefits

An FDA panel says Opana ER has more risks than benefits. (AP Photo/Rich Pedroncelli, File)

By    |   Thursday, 16 Mar 2017 03:38 PM

An FDA advisory panel has decided the risks posed by Opana ER, a strong opioid painkiller, are greater than its benefits. The risks are related to its use as an abused drug.

Drugmakers reformulated the medication in 2012 to make it harder to crush in an attempt to prevent abusers from snorting the drug, but it didn’t take long for users to figure out they could dissolve the pill and inject it instead.

A 2015 HIV outbreak in Scott County, Indiana, was linked to the sharing of needles to inject Opana ER, NPR reported. Nearly all IV drug users in the area who tested positive said they had injected Opana ER.

In a larger survey of people entering drug treatment for abusing Opana ER, about double, or 38 percent, said they had injected it after the reformulation compared to before, NPR reported.

The FDA usually follows panel recommendations, but it is not required to do so. It may decide to change the labeling on the product, put more restrictions on prescribing it, or remove it from the market completely, Reuters reported.

Panelist Ronald Litman pointed out that if oxymorphones — generics in the same class — remain on the market in any form, Opana ER could benefit patients because of its abuse-deterrent properties, according to Reuters. Other panelists said they didn’t know whether they should really consider the risk-benefit profile for addicts rather than for the intended users of the drug.

“I strongly believe there is no place for oxymorphone in American society today,” Litman said, Reuters reported. “But that’s not what you asked me.”

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An FDA advisory panel has decided the risks posed by Opana ER, a strong opioid painkiller, are greater than its benefits. The risks are related to its use as an abused drug.
fda, panel, opana er, risks, benefits
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2017-38-16
Thursday, 16 Mar 2017 03:38 PM
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