The benefits of Opana ER, a long-acting opioid pain killer, no longer outweigh its risks, two advisory committees to the U.S. Food and Drug Administration decided in a joint meeting last week.
Committee members voted 18-8, with one abstention, in making their conclusion regarding the extended-release formulation of oxymorphone hydrochloride. Opana ER is sold by Endo International Plc.
While the FDA will consider the committees’ vote, it’s up to the agency to decide whether to take any action such as revising the drug’s labeling or taking it off the market.
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