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Zohydro too dangerous for FDA’s OK?

Is Zohydro too dangerous?

FED UP!, an organization of over 40 consumer, health care and addiction-rehabilitation groups, thinks Zohydro is indeed too dangerous and they are urging the FDA (U.S. Food and Drug Administration) to reverse its approval of the new painkiller.  Zohyrdo is one of the drugs known as an opioid analgesic and was “green-lighted” by the FDA this past fall despite noteworthy reticence from the Fed’s own advisory committee which records show voted 11 to 2 against permitting the sale of Zohydro.

One concerned coalition, Public Citizen, claims that one dose of the highly addictive, hydrocodone-based drug Zohydro could kill a child.  The formal petition submitted to the Food and Drug Administration states that Zohydro is just too dangerous and goes on to say that there is simply no need for yet one more “high-dose opioid” or painkilling prescription narcotic.


Zohydro approved . . . but for how long?

In a media-shared letter to Dr. Margaret Hamburg, FDA Commissioner, FED UP! wrote: “In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid.  Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

In an earlier interview with CNN Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, the pharmaceutical company behind Zohydro, stated: “We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids.  In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”

Galer is confident that Zogenix will only target sales of Zohydro to a specific portion of the health care community and will focus on doctors who have exceptional experience prescribing prescription narcotics.  This will result in Zohydro only being given to “an appropriate group of patients” who suffer from chronic pain.

Both Zogenix and the Food and Drug Administration agree that the many benefits of Zohydro far outweigh any potential risks.  Furthermore Zogenix stated that Zohydro will be marketed with numerous warnings concerning abuse, potential addiction and possible misuse.  Regardless of these assurances, however, some doctors remain concerned.

Dr. Charles Reznikoff of the Hennepin County Medical Center in Minneapolis, Minnesota told the press: “The technology is out there to make this a safer pill. They just chose not to use it.  I would never prescribe it or recommend that it be prescribed. I would also recommend that the insurance companies not make it available to patients.”

Despite this cornucopia of cautious concern over the addictiveness of all opioid analgesics, patients with chronic pain will have access to Zohydro as early as next month.

(Image courtesy of PainAndDepression)

About Will Phoenix

W. Scott Phoenix, B.A., B.S. was born in Hawaii, raised in Pennsylvania and resides in California. He has been a published writer since 1978. His work has appeared (under various names) in numerous places in print and online including Examiner.com. He is a single parent of three children and has also worked as an actor, singer and teacher. He has been employed by such publications as the Daily Collegian and the Los Angeles Times.