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Zohydro Painkiller Approved Despite Warnings to FDA about PotentialAddiction and Loss of Life

Despite mounting concern over its potency and addictive properties, the new painkiller Zohydro ER was approved by the US Food and Drug Administration (FDA), and is now available by prescription. The drug may be available, but that’s not stopping a large coalition from pleading with the FDA to rethink its decision. The coalition, made up of patients, addiction specialists, doctors and lawyers are predicting a, “major loss of life,” related to the drug.

Zohydro is a slow-release, hydrocodone-based drug created for the management of severe and chronic pain sufferers. The problem, some experts say, is with its high potency. The highest dose of Zohydro will contain 5 – 10 times more hydrocodone than Vicodin or Lortab, and that’s in a single pill. According to 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. It will kill people as soon as it’s released.”

Before the drug was unleashed onto the market, a large coalition made up of doctors, safety organizations, healthcare agencies, addiction specialists and more, addressed Margaret A. Hamburg, M.D., Commissioner of the FDA in a letter written one week before Zohydro’s expected launch date. In the letter, coalition members laid out a cogent argument for the FDA’s reconsideration. The letter started by reminding Hamburg that the FDA’s own scientific advisory panel voted 11-2 against approval.

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