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28 State AGs Ask FDA to Reconsider Approval of Zohydro ER Because of Abuse Potential — Physician’s First Watch

Medical News |
December 16, 2013

28 State AGs Ask FDA to Reconsider Approval of Zohydro ER Because of Abuse Potential

By Kelly Young

Twenty-eight state attorneys general have asked the FDA to reconsider its approval of Zohydro ER, a hydrocodone-only painkiller, or consider an expedited schedule for developing an abuse-deterrent version.

In a letter to FDA commissioner Margaret Hamburg, they write that Zohydro ER is up to 10 times as potent as other hydrocodone products and currently does not contain any abuse-deterrent properties.

They refer back to the approval of other prescription painkillers like Oxycontin, which was also easy to abuse when it first entered the market and did not come with clear prescribing instructions. They write: "This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors overprescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives."

Reader Comments (3)

kristina nadreau dvm Other, retired

The decisions about analgesia are best made by the physician and the ppatient and ONLY the physician & patient. There must be NO interference from buerocrats & government,.

The myth that drug abuse can be controlled by controlling supply is laughable, as we have 40 years of clinical data disproving the myth. Furthermore the most commonly abused drug which results in the most deaths, injuries and damage to property is alcohol, not the opioids. Data and simple observation points out that a small % of the population is addiction prone and will seek and find some agent to feed their cravings regardless of attempts to control supply. Lastly, if my pain requires a stronger analgesic, and I then become addicted, so be it! If I must choose between pain and addiction, I will choose addiction. I f I lose my life attempting to live pain free, again, this is rightfully my choice.

LARNEY SAGER Physician, Anesthesiology, Retired

I have nothing to add as your comment said it all.
The people in power know all this. They just have to stop being so money hungry and not get involved in medicine.

Dr. Don Gentry Other, Dentistry, Retired

It seems to me that the peristaltic inhibition of opiates is sufficient deterrent.

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