Organizations Urge FDA to Reverse its Approval of Prescription Painkiller Zohydro ER
A recent article published in the British Medical Journal on March 3, 2014 reports that over 40 consumer groups, addiction treatment organizations, and healthcare agencies have called on the United States Food and Drug Administration (FDA) to reverse its recent approval of a potent oral opioid drug they say threatens to worsen a widespread addiction to prescription drugs. Those organizations who wrote a letter to the FDA urging them to reverse its decision included the following organizations: American Society of Addiction Medicine, Physicians for Responsible Opioid Prescribing, and the consumer advocacy group Public Citizen.
The drug, Zohydro ER, is an extended release formulation of hydrocodone bitartrate that can provide relief for up to 12 hours per dose, per the FDA’s review. It was approved by the FDA on October 25, 2013.
However, Forbes reports that the new opiate painkiller, with 5-10 times the power of Vicodin, could trigger a disastrous spike in overdoses and deaths. “In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the experts wrote when addressing FDA Commissioner Margaret A. Hamburg, MD. One member of the coalition who urged the FDA to reconsider its decision was Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, who said: “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released.”
Forbes adds that this isn’t the first group of experts to beg the FDA to reconsider. A coalition of Congressional representatives and state Attorney Generals has also urged the FDA to listen to its own advisory panel, which voted 11 to 2 against approving Zohydro. Additionally, many experts are surprised that Zohydro ER was approved without an “abuse-deterrent” formulation, meaning additives would be included to cause unwanted side effects when the drug is used improperly, rather than as prescribed.
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