Critics call the drug "heroin in a pill."
Zohydro ER is made by the San Diego company Zogenix.
The extended-release painkiller is packed with hydrocodone, a widely abused narcotic.
An FDA advisory committee voted against putting it on the market. But the agency decided to release the drug anyway.
Natalie Costa made a film about drug abuse called "Behind the Orange Curtain." She said Zohydro is dangerous, because it doesn't have a tamper-resistant coating that prevents it from being crushed.
“This medication will kill you, if it’s taken incorrectly, if it’s broken in half, if it’s crushed, snorted or shared. Ten Vicodin in one capsule, that’s what Zohydro is," Costa said.
Dr. Gregory Smith, a Los Angeles pain specialist, says it's exceedingly rare to find a patient who doesn't respond to one of the many well-established painkillers on the market.
He thinks the FDA should pull Zohydro until it's reformulated with abuse-resistant features.
The FDA says its goal is to balance concerns about drug abuse with the need to provide access to effective painkillers.
