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Groups ask FDA to revoke approval of powerful opioid Zohydro

Thursday February 27, 2014
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More than 40 healthcare agencies, consumer organizations, addiction treatment providers and community-based drug and alcohol prevention programs called on the Food and Drug Administration to revoke its approval of the opioid Zohydro.

The medication is so powerful that a single dose could kill a child, according to a news release from Public Citizen, one of the groups that signed a letter to the FDA.

The Public Citizen news release noted that the FDA approved the drug in October against the advice of its own advisory committee, which voted 11-2 against allowing Zohydro, made by Zogenix and Alkermes, to be sold. Scheduled to be available in March, it is the first single-ingredient hydrocodone drug ever to be approved. Other drugs, such as Vicodin, combine hydrocodone and acetaminophen.

Earlier this month, three U.S. senators raised concerns about the drug and asked the FDA to explain how it will prevent misuse.

Writing on behalf of “groups on the frontline of the nation’s opioid addiction epidemic,” the organizations said there is no need for another high-dose opioid.

Opioid prescriptions have skyrocketed in recent years, according to the news release. The U.S. includes 5% of the world’s population yet consumes more than 99% of the world’s hydrocodone. Opioid addiction and overdose deaths have increased commensurately.

“I’m amazed that the FDA would approve a dangerous new opioid over the strong objection of its advisory panel,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in the news release. “In the midst of a severe epidemic of opioid addiction and overdose deaths, this is the last thing we need.”

Upon approving the drug, the FDA stated: “Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.

“Zohydro ER is in the class of extended-release/long-acting opioid analgesics. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.”

Full letter (PDF): www.citizen.org/documents/2185.pdf

FDA approval notice: www.fda.gov/newsevents/newsroom/pressannouncements/ucm372287.htm


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