In recent months considerable controversy has surrounded the release of Zohydro – a newly patented form of hydrocodone from drug maker Zogenix Inc. The new formulation was approved by the FDA for sale in the United States last October despite objections by the FDA's own advisory committee (which voted 11-2 to not approve the drug). Since that time:
- A coalition of addiction treatment experts has urged the FDA to revoke its approval of Zohydro
- Congressmen and Attorneys General from 28 states and the District of Columbia have asked the FDA to reconsider its decision
- Governor Deval Patrick of Massachusetts declared a public health emergency to ban the prescribing and sale of Zohydro (which has since been stayed by a federal court judge)
- A New Hampshire Senate committee introduced legislation that would impose an 18-month moratorium on Zohydro
- Vermont Governor Peter Shumlin devoted his entire annual address to the “full-blown heroin crisis” in the state of Vermont.
While approval and sale of Zohydro is meeting with popular and political objection, medical opinion on the new drug is less congruous. Zohydro doesn’t contain acetaminophen (like many of the most popular forms of hydrocodone-containing products that preceded it). Many physicians look to Zohydro for an important clinical tool that might serve as relief for those at risk for liver toxicity and suffering from severe pain. This is a valid clinical view.
Annual ED visits resulting from acetaminophen overdose: 56,000
Annual ED visits resulting from opioid overdose: 500,000… 10X that of acetaminophen.
Annual hospitalizations from acetaminophen overdose: 26,000
Annual hospitalizations from opioid overdose: 1,300,000… 50X that of acetaminophen.
Annual deaths resulting from acetaminophen overdose: 450
Annual deaths resulting from opioid overdose: 16,000… 35X that of acetaminophen.
People addicted to acetaminophen: 0
People addicted to opioids: millions
PRIUM has begun to see Zohydro in our peer reviews. We've only seen a few scripts, but it's clear in the cases we've seen thus far that acetaminophen concerns are not the driving factor for the doctors prescribing the new drug. Rather, it seems they're simply trying the market's newest opioid analgesic.
Is the safety profile of Zohydro, due to its lack of acetaminophen, sufficiently compelling for us to ignore the inclusion of yet another opioid in the midst of this epidemic?
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On Twitter @PRIUM1