The Food and Drug Administration said Thursday it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER, after concluding the drug’s risks outweigh its benefits.
It’s the first time the FDA has asked a drugmaker to remove an opioid painkiller from the market. The agency said it has seen a “significant shift” from people crushing and snorting Opana ER to get high to injecting it.
Endo said in a statement it’s “reviewing the request and is evaluating the full range of potential options.”
Wall Street responded quickly with a sell-off, and Endo shares plunged 13.4 percent to $11.93 in trading after U.S. markets closed.
The FDA move comes after advisers, reviewing the safety of Opana ER at a March hearing, voted 18-8 against keeping it on the market.
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