FDA Advisory Committee Finds Opana ER Risks Outweigh Benefits

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on March 21, 2017 | Posted by Erin O'Neill, PA-C, JD

On March 14, 20shutterstock_26806771417, a Food and Drug Administration (FDA) advisory committee found that the risks associated with use of Opana ER (oxymorphone hydrochloride) outweighed the potential benefits.

Opana ER is an opioid pain medication, which was first introduced in 2006 and then reintroduced in a new abuse deterrent formulation in 2012. The new formulation was designed to prevent users from crushing and snorting the medication; however, critics have opined that the new formulation may have made the drug easier to inject. Over the past few years, the drug has been linked to multiple healthcare crises including a cluster of HIV cases and an outbreak of thrombotic thrombocytopenia purpura (TTP) as well as multiple reports of drug overdose from injecting the medication.

The exact effect of the advisory committee’s findings on the future of the drug is unknown at this time. If the FDA agrees with the advisory committee’s findings, the agency could end up requiring changes to the medication’s label, placing restrictions on use or even possibly withdrawing the medication from the market altogether. Opana ER is widely used in workers’ compensation cases, and consequently is allocated in many MSAs, due to its wide use. However, with these recent findings the future of Opana ER remains to be seen, and we may begin to see less and less of this drug in MSAs.

Additional information regarding the advisory committee’s proceedings can be viewed here.