Drugmaker’s stock plunges after FDA asks them to stop selling abused painkiller – PB/TK
FDA to drugmaker: Yank opioid Opana ER from market – AP / June 9 2017
U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it.
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.
Besides contributing to overdoses, abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles, according to the FDA.
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