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Feb. 26, 2014

Dozens of Groups, Experts Call on FDA to Withdraw Its Approval of Zohydro, Supercharged Opioid

A Single Dose Could Kill a Child; FDA Approved Drug Despite Overwhelming Negative Advisory Committee Vote

WASHINGTON, D.C. – More than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs today called on the U.S. Food and Drug Administration (FDA) to revoke its approval of Zohydro, an opioid so powerful that a single dose could kill a child.

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. It is the first single-ingredient hydrocodone drug ever to be approved. Other drugs, such as Vicodin, combine hydrocodone and acetaminophen. Zohydro is scheduled to be available in March.

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 front-line of the nation’s opioid addiction epidemic,” the organizations said there is no need for another high-dose opioid.

“Too many people have already become addicted to similar opioid medications and too many lives have been lost,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “The FDA should exercise its responsibility to protect the public’s health by reversing its approval of Zohydro.”

“I’m worried about their plan to market the drug for back pain and other common problems,” said Judy Rummler, chair of the FED UP! Coalition and president of the Steve Rummler Hope Foundation.  Judy’s son Steve died of a drug overdose in 2011.  He had become addicted to the painkillers that were prescribed to him for his chronic back pain.

Opioid prescriptions have skyrocketed in recent years. The U.S. has just 5 percent of the world’s population but is consuming more than 99 percent of the world’s hydrocodone. Opioid addiction and overdose deaths have increased commensurately.

“The capsules will contain a whopping dose of hydrocodone,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids. Jackson lost his 18-year-old daughter to a single dose of OxyContin. “It’s crazy to let this drug go on the market as it undoubtedly will become the next OxyContin that will fuel the opioid addiction epidemic.”

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

The letter is available at http://www.citizen.org/hrg2185.

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