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Critics Oppose FDA Approval of Painkiller Zohydro


Q. What is Zohydro’s selling point?

A. Zohydro is the first medication that contains only hydrocodone, as opposed to hydrocodone plus acetaminophen (marketed as Lortab and Vicodin) or hydrocodone plus ibuprofen (Vicoprofen).  Zogenix says acetaminophen overdose is a leading cause of sudden liver failure in the U.S. Nearly two-thirds of those overdoses are attributed to medications that include hydrocodone and acetaminophen, Zogenix says.

But patients with liver failure have multiple acetaminophen-free opioids to choose from, Kolodny says. And, Jerry says, “acetaminophen acts as a deterrent to addicts. They know it’s toxic to the liver.”

Q. Who is Zohydro supposed to treat?

A. According to the FDA-approved labeling, Zohydro is "for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternate treatment options are inadequate.” The manufacturer can’t market it for other uses, but doctors are free to prescribe it to any patient they deem appropriate.

Q. Are there other treatments for people with chronic pain?

A. With a variety of other opioids on the market, Kolodny says, no one needs Zohydro. He and Jerry also say there is little research into whether opioids relieve non-cancer pain, such as that from osteoarthritis, beyond 3 months or so.

Opioids are “lousy drugs for non-cancer chronic pain,” says Kolodny, who also is medical director of Phoenix House, a nonprofit organization that provides alcohol and drug abuse treatment and prevention services in 11 states.

Physical therapy and cognitive behavioral therapy can help relieve non-cancer chronic pain, Kolodny says. “You can take Tylenol (acetaminophen) and Advil (ibuprofen) and get pretty good pain relief.” On very bad days, people could take a Vicodin, Kolodny says. “And the opioid works, because they’re not building up tolerance.”

Q. Is it unusual for the FDA to go against the recommendation of one of its advisory committees?

A. The agency does sometimes approve a drug that an advisory committee rejected or turns down a drug that an advisory committee endorsed, says Michael Carome, MD. He is director of the Public Citizen health research group, which is among the organizations asking the FDA to reverse its approval of Zohydro.

“In general, the more lopsided the vote, the less likely FDA will go against the recommendation of its advisory committee, but it does on occasion happen,” Carome says.


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