Advocates Urge FDA to Revoke Approval of Painkiller Zohydro

More than 40 addiction treatment, health care and consumer groups are urging the Food and Drug Administration (FDA) to reverse its decision to approve the prescription painkiller Zohydro ER (extended release), CNN reports.

The drug is a pure form of the painkiller hydrocodone. The FDA approved Zohydro ER in October for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen. Zohydro ER is set to become available in March, the article notes.

In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction.

Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. The opioid drug OxyContin has been reformulated to make it harder to crush or dissolve, but Zohydro does not include similar tamper-resistant features.

In a letter to FDA Commissioner Dr. Margaret Hamburg, the coalition of health groups, wrote, “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.”

The health groups include the American Society of Addiction Medicine, Public Citizen Health Research Group, Phoenix House, the Hazelden Foundation, and Physicians for Responsible Opioid Prescribing.

In December, 28 attorneys general wrote to Commissioner Hamburg, saying they believe 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.”