Controversial Painkiller Zohydro Being Geared Up for Release

By McCarton Ackerman 03/11/14

The first pure hydrocodone painkiller approved by the FDA will hit the market this week barring a last-minute repeal.


The powerful painkiller Zohydro is scheduled to hit U.S. markets this week, but health care advocates are desperately pushing for a last-minute repeal. As it stands, such a reprieve looks unlikely.

Zohydro seeks to provide relief for those suffering from chronic pain conditions such as fibromyalgia and arthritis, but the drug has raised eyebrows due to it being the first pure hydrocodone medication to be approved by the U.S. Food and Drug Administration (FDA), in addition to the controversial manner in which it was approved.

Concerns of Zohydro abuse and addiction were heightened further due to the pills being easily crushable, meaning the medication can be snorted or injected. Although Zogenix, the manufacturers of Zohydro, announced plans to release a non-crushable version of the drug, it will take one to three years for it to hit the market. Zohydro is also up to five times stronger than other opioid medications for pain management that are currently on the market, including Vicodin and Oxycontin. “It will kill people as soon as it’s released,” said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule.”

The drug was approved by the FDA last October despite the advisory committee they brought together voting against releasing it by 11-2. U.S. senators Joe Manchino (D-WV) and David Vitter (R-LA)  have since launched a bribery investigation after an FDA official allegedly accepted money from pharmaceutical companies in order to obtain a seat on an FDA advisory panel meeting; a spokesman for the FDA has denied the allegations.

Statistics from The Centers for Disease Control and Prevention show that prescription opioid deaths have quadrupled since 1999, from 4,030 in 1999 to 16,651 in 2010. Meanwhile, painkiller abuse has been instrumental in the surge in heroin addiction over the last few years.

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McCarton Ackerman is a freelance writer and editor living in Portland, Oregon. He has been a contributor for The Fix since October 2011, writing on a wide range of topics ranging from medical marijuana in Colorado to the world's sexiest drug smugglers. Follow him on Linkedin and Twitter.