Attorneys General Challenge Approval of Zohydro

It’s an ongoing process to monitor the prescription medications that we use, and history shows us that despite the Food and Drug Administration’s oversight, meds do make it to market that are later proven harmful. Over the years, dozens of drugs have been pulled after reports of dangerous side effects or death.

The most recent medication being scrutinized is the powerful narcotic painkiller Zohydro, which has become divisive before even hitting the market. Also known as hydrocodone bitartrate, the drug would be the first hydrocodone-only drug in the US. In October 2013, the FDA made the decision to go against the recommendation of its own advisory committee and approved the drug. Now, the attorneys general from 28 states have asked the government to reconsider that approval.

Americans & Hydrocodone

  • Americans consume 99% of the hydrocodone used in the world
  • 131 million Vicodin prescriptions were filled in 2010
  • In 2010, 16,000 people died of overdoses from narcotic painkillers
  • Hydrocodone is the opioid found in drugs like Vicodin, a medication that also includes over-the-counter pain relievers such as acetaminophen or ibuprofen. Unlike Vicodin, Zohydro ER will come in doses that will contain five to 10 times more heroin-like narcotic than traditional hydrocodone products. Its slow release formulation also makes it a perfect candidate for abuse. Meant to be released into the body in a steady stream over 12 hours, those looking for a powerful high can crush it, chew it, or mix it with alcohol to get the full effect all at once. In recent years, other powerful painkillers have been released in abuse-limiting formulations that attempt to foil those trying to misuse the medications.

    Americans already consume 99 percent of the hydrocodone used in the world. In 2010, Vicodin was the most prescribed medication in the US, with 131 million filled prescriptions. That same year, more than 16,000 people died of overdoses from narcotic painkillers, nearly a 400 percent increase from just a decade earlier.

    The 28 attorneys general are asking the FDA to reconsider its decision or set a timeline for the manufacturer to reformulate Zohydro with abuse-deterrence.

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