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.

approved with pills

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.

The coalition letter warned, “The very last thing the country needs is a new, dangerous high-dose opioid.” Citing statistics from the Center for Disease Control (CDC) they revealed, “The United States, with about 5% of the world’s population, is now consuming more than 84% of the world’s entire oxycodone supply and more than 99% of the hydrocodone supply.”

Zohydro supporters say the drug is less dangerous because it does not contain acetaminophen, but experts say the single high dose of hydrocodone is far more troubling than potential liver damage.  Try using a painscale.

Regarding approval, the FDA said, “The benefits of this product outweigh the risks. . . Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

The coalition letter calls for an, “Urgent revision to FDA policies.”