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.
However…
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?
Though I sympathize with addiction concerns, in the end, responsible patients should NEVER be restricted or denied access to any medication because of those who abuse, misuse and divert. Zohydro is a very valid alternative for anyone currently taking Vicodin, Lortab or other combo hydrocodone formulas, or anyone who is needing to try a different pain med because of tolerance issues. Millions of legitimate patients take these medications for legitimate pain and certainly deserve a choice that does not subject them to the risks of liver toxicity from acetaminophen combo products. Your facts are somewhat obscure as to actual causes of death from specific opioids. You omitted looking just hydrocodone overdose (the most common prescribed are Vicodin, Lortab, and generics). Hydrocodone is not the 'preferred high' of abusers and less abused and in a majority of hydrocodone overdose cases the added ingredient of acetaminophen was the actual cause of overdose, but many times may not have been reported as such so the stats could be even higher. In many overdose cases, the opioid was combined with other things like alcohol or other illegal drugs that aggravate the issues. Many of the stats simply just don't report all the details that clearly. When we have 100s of thousands more each year that die from smoking and alcohol combined than prescription painkillers, this frenzy seems a bit misplaced.
ReplyDeleteGood points, all. A couple of thoughts in response:
DeleteFirst, you mention that "millions of patients... deserve a choice that does not subject them to the risks of liver toxicity." I'm sure you meant to say that doctors deserve that choice, not patients. While this seems like a nitpick, patient-driven care is one of the most dangerous aspects of the opioid epidemic. Doctors should be choosing the clinically appropriate medications for pain - not patients.
You're right that the statistics are muddy on opioid overdose deaths. I was simply pointing out that the magnitude of impact, from a public health standpoint, is significantly greater. While I acknowledge the potential clinical benefit of Zohydro to a given individual patient, the drug is serving as a lightning rod for the broader debate on prescription opioids. The "frenzy" to which you accurately refer isn't really about Zohydro, it's about the state of pain management and the opioid epidemic in general. Zohydro just happens to be taking most of the heat due to the fact that it's new, it was approved over the objection of the FDA's own advisory committee (11-2), and it's lack of tamper resistant formulation. I don't necessarily think it's fair to Zogenix, the specific drug Zohydro, or to the patients who might benefit from it. But these are the times in which we live...