Pharmaceutical

FDA panel says Opana ER too dangerous to stay on the market

fda logo FDA panel says Opana ER too dangerous to stay on the market A Food and Drug Administration (FDA) advisory panel charged with reviewing safety concerns with the powerful opioid Opana ER, determined that the risks outweighed the benefits, a decision that could lead to a market withdrawal.

Opana ER is made by Endo Pharmaceuticals and is an extended release version of the painkiller oxymorphone. The company was granted approval from the FDA in 2006 to market an immediate-release oxymorphone called Opana IR. The patent expired in 2011, and Endo responded with an extended-release (ER) version that had been formulated with an “abuse deterrent” coating. The FDA told opioid manufacturers that it will only approve new opioids if they have abuse deterrent properties that make them more difficult to crush and be snorted or dissolve and be injected – both of which would give abusers a powerful high.

But, Endo discovered problems with its abuse-deterrent coating when it came to dissolving the pills. During a review by the FDA whether to include abuse deterrence on the safety labels of the drug, the FDA raised serious concerns. Data suggested that while there is a decrease in abuse with snorting Opana ER, there was an increase in abuse of the drug through injection.

Furthermore, the FDA noted a risk for serious blood disorders with Opana ER when it is dissolved and injected, a condition called thrombotic thrombocytopenia purport that it said may be caused by the abuse-deterrent coating.

The FDA will take under advisement the recommendations of its advisory panel to decide whether stronger warnings should be applied to the drug’s label or if it should be pulled from the market, as the panel recommended. The agency isn’t required to follow the advice of its panel, but it usually does.

Sources:
Law360
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