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Wednesday, February 26, 2014

Health Group Coalition Against FDA's Approval of Zohydro

The Food and Drug Administration (FDA) is being strongly urged to reverse its approval of Zohydro ER (extended release) before its set release date of March 2014, according to CNN. The drug, approved last October, is pure hydrocodone, the narcotic opioid ingredient of Vicodin. Most prescription painkillers are a combination of opioids and non-narcotic drugs like acetaminophen. Combination drugs are much harder to abuse than pure opioids like OxyContin (oxycodone) and potentially Zohydro (hydrocodone).

A coalition of health care and consumer groups, as well as 40 addiction treatment centers, has joined together in the fight against the FDA’s decision to approve a drug that, without question, will be heavily abused, CNN reports.

Health groups include:
  • The American Society of Addiction Medicine
  • Physicians for Responsible Opioid Prescribing
  • Public Citizen Health Research Group
  • Phoenix House
  • The Hazelden Foundation
Nearly two years ago, a panel of experts created by the FDA, in the field of addiction and prescription drugs, voted against Zohydro. The panel voiced overwhelming concerns about the dangers of abuse and the potential for addiction.

What’s more, Zohydro ER lacks tamper-resistant features that would make the drug more appealing to experts. The drug can be crushed or dissolved, making it easy for users to either snort or inject the medication. Such problems were also associated with the drug OxyContin; however, the brand name OxyContin has been reformulated making it more difficult for users to tamper with the medication.

In December, 28 attorneys general wrote to FDA Commissioner Dr. Margaret Hamburg regarding Zohydro, they said that the approval of Zohydro ER “has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties.”

The coalition of health groups opposed to Zohydro wrote a letter to Commissioner Hamburg, which stated, “In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid. Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

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