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Groups Ask FDA to Keep Zohydro ER Hydrocodone Off the Market — Physician’s First Watch

Medical News |
February 27, 2014

Groups Ask FDA to Keep Zohydro ER Hydrocodone Off the Market

By Kelly Young

A coalition of consumer safety organizations, addiction treatment providers, and healthcare groups has asked the FDA to reconsider its approval of the high-dose hydrocodone capsule Zohydro ER because of its abuse potential. In December, 28 state attorneys general made a similar request.

In a letter to the FDA, the coalition wrote: "In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid."

The group contends that Zohydro ER is not safer than hydrocodone products already on the market, even though it doesn't contain acetaminophen. The highest Zohydro ER dose (50 mg) will have five times more hydrocodone than the highest dose of Vicodin (10 mg), the group says. An opioid-naive individual could have a fatal overdose after taking two capsules, and a single capsule could be fatal to a child.

Zohydro ER was FDA approved in October 2013.

Reader Comments (4)

Don Gentry, DDS, Ret'd., Corpus Christi, TX Other Healthcare Professional, Dentistry, Retired

I agree with Dr. Felix. We can do better than allowing abuse potential to dictate the availability of drugs. In addition to his suggestions, clear label warning requirements can help address accidental overdose potential. In patients with hepatic metastases, or others with compromised liver function and severe pain, a better oral analgesic without acetaminophen is much needed.

Don Gentry, DDS, Ret'd., Corpus Christi, TX Other Healthcare Professional, Dentistry, Retired

I agree with Dr. Felix. We can do better than allowing abuse potential to dictate the availability of drugs. In addition to his suggestions, clear label warning requirements can help address accidental overdose potential. In patients with hepatic metastases, or others with compromised liver function and severe pain, a better oral analgesic without acetaminophen is much needed.

Carol Vassar, MD Physician, Internal Medicine, pvt practice

Do we need a long acting hydrocodone? Is it in a form that if crushed or chewed it would not release all of the oxcodone at once? While standardized practice helps, -and you could include pill counts and contracts to your list of important practices- we still have very tough problem with increasing overdose deaths. If hydrocodone in a long acting form is really more valuable than methadone or fentanyl, I would rather see it as a patch from which the drug could not be removed for oral or IV use.

ROGER FELIX Physician, Family Medicine/General Practice, Albuquerque

I don't believe that keeping long-acting opioids off the market is the key to solving the prescription opioid crisis. Although I quite agree that such a crisis of dependence, overdose, and death indeed exists, prohibiting specific medications isn't likely to contribute much. Many experts on treatment of chronic non-cancer pain agree that long-acting opioids taken on a regular schedule helps to avoid dose escalation in patients on chronic doses of opioids, and I have witnessed that "on the ground." The real keys to ending the prescription opioid crisis include formalizing chronic pain management (so that not anyone can hang out a shingle and say that they manage chronic pain while having zero understanding of this part of medicine, as I've personally witnessed happening in this city a number of times), standardizing the practice of chronic pain management (so that very little deviation from standards agreed upon by the academic community in this field is tolerated), and making it attractive to enter this specialty while simultaneously adhering to such well-established guidelines (guidelines such as frequent drug testing, use of non-opioid adjuvant medications, use of non-pharmacologic interventions -- which would have to be covered by health plans -- and consistent consultation of state pharmacy board records). I could retire now if I'd received a thousand bucks for every patient I'd seen who'd been to multiple physicians for opioid prescriptions who I turned away because of a stunning record of doctor-shopping exposed by the NM Board of Pharmacy controlled substance log. If all our clinicians just used that log regularly, it would go a long way toward keeping so many opioids off the streets. However, the patients with legitimate uncontrolled chronic pain still need somewhere to go for treatment. Their options in this region are limited, and some of those options aren't that legitimate themselves.

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