INDIANAPOLIS - Indiana's attorney general is working to get a new powerful painkiller taken off the market amid increasing concerns on how it could affect the health and safety of consumers.
Experts have warned of Zohydro’s potency and are concerned about the potential risk for abuse.
Dozens of doctors and addiction experts are urging the Food and Drug Administration to revoke its approval of what they says is a dangerous, high-dose drug.
The prescription painkiller is 10 times more narcotic than Vicodin, experts say.
"It's just another potentially dangerous drug and some prescribers might not recognize the full level of danger with this drug," Fairbanks Medical Director Dr. Tim Kelly said.
The FDA says that the recently launched Zohydro fills an important and unique niche for treating chronic pain -- despite its own advisory committee voting overwhelmingly against releasing the drug to the public.
Even the drug’s prescribing literature warns that "accidental consumption of even one dose of Zohydro ER, especially by children, can result in a fatal overdose of hydrocodone."
Officials with the Indiana State Department Of Health said prescription drugs were responsible for the deaths of more than 700 people in 2011.
There are growing concerns about the potential abuse of the new drug.
"It can be crushed and snorted. It can be made into a liquid and injected," Indiana Attorney General Greg Zoeller said.
Zoeller joins five other attorneys general in calling on the U.S. Department of Health and Human Services to overturn the approval of Zohydro.
"Why would they open this up into the market against their own advisors, against the medical communities and against attorneys general that are trying to fight this," Zoeller said.
The drug’s maker said there have been gross misstatements about the drug’s potency and defends its safety, despite the uproar from doctors and law enforcement.
Critics say that regulators should have required that Zohydro be formulated in a way that would make it hard for abusers to chew, crush or dissolve the drug, because that could result in a massive -- and potentially fatal -- dose.
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