The hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.”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,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.”Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”
One addiction expert who signed the letter was more forthright. “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.” The letter is the latest in a series of entreaties to the FDA related to Zohydro. In December, 29 state attorneys general sent a similar letter to the FDA. The month before, members of Congress asked the agency to review its decision to approve the drug. The concerns echoed by all groups are broadly about the drug’s potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers. “This could be the next OxyContin,” says a petition on Change.org asking the FDA to reconsider.
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