WASHINGTON — The Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely abused prescription painkiller.
The agency said Friday it approved the extended-release pill Zohydro ER for patients with pain that requires ''daily, around-the-clock, long-term treatment'' that cannot be treated with other drugs.
Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis, and migraines. The new drug from Zogenix is the first pure hydrocodone drug approved in the United States.
The approval came as a surprise since the agency's own panel of outside advisers gave the drug an overwhelmingly negative review last year. The panel of pain specialists voted 11 to 2, with one abstention, against approving the drug, questioning the need for a new form of one of most widely abused prescription drugs in the United States.
Zohydro's approval was quickly criticized by patient safety advocates who had urged the FDA to reject the drug at the public panel last December.
''We're just going to kill more kids and then the FDA is going to come back and say, 'oh, we made a mistake,' '' said Avi Israel of Buffalo, N.Y. Israel's son Michael committed suicide in 2011 while struggling with painkiller addiction. Israel is the founder of a group that aims to combat painkiller abuse in young people.