Late last year, the U.S. Food and Drug Administration shocked the medical community when it approved Zohydro ER, a long-lasting and potent form of the opiod drug hydrocodone. The reason it came as a surprise to many was because the decision was made in direct opposition to the disapproval by the agency’s Anesthetic and Analgesic Drug Advisory Committee, comprised of independent experts who raised concerns about both the drug’s safety and potential for abuse.
Now, as Zohydro hits the market, even more voices are joining the fray, urging the FDA to halt sales of the drug until more research can be conducted. Opponents include 28 attorneys general and legislators who have introduced bills in both the Senate and House seeking to have FDA approval of the drug withdrawn. Additionally, an open letter signed by a coalition of more than 40 health care, addiction treatment and consumer groups strongly urges the FDA commissioner to revoke approval.
However, our product liability lawyers understand that as of this writing, those efforts have been unsuccessful.
Zohydro is essentially pure hydrocodone in a dose far higher than what is found in other drugs, such as Lortab or Vicodin. A single dose of Zohydro contains 5 to 10 times more hydrocodone than these other drugs. The FDA has clearly specified that it is only to be used by patients for whom other painkillers either aren’t effective or their systems won’t tolerate them. But according to critics, a person could die after consuming just two tablets back-to-back.
Plus, unlike other painkillers, Zohydro is very easy to crush, meaning the abuse and danger potential is further heightened.
As it already stands, painkiller addiction is a major problem in this country. In 1999, the U.S. Centers for Disease Control and Prevention reported that approximately 4,000 people in this country died as a result of opioid painkiller overdoses. Over the course of a decade, that figure more than quadrupled, to nearly 17,000 by 2010.
In a letter penned by the 28 attorneys general to the FDA commissioner last December, it was noted that whenever potent painkillers enter the market absent sufficient abuse-deterrents, it begins a vicious cycle of overzealous pharmaceutical sales, overprescribing by doctors, and patients tampering with, abusing and selling the drug on the black market. The U.S. consumes 99 percent of hydrocodone used in the world.
While the FDA is not beholden to the attorneys general or even its own advisory committee, these entities usually hold significant sway in the ultimate decisions made by the agency.
The president for the group Physicians for Responsible Opioid Prescribing was recently quoted as saying that Zohydro “will kill people as soon as it’s released.”
While the FDA enjoys immunity and likely could not be pursued in litigation for any deaths or damages that result from the release of Zohydro, the manufacturer could, and so could physicians who prescribe it irresponsibly. Given the drug’s potency and potential for abuse and overdose, we fully expect such cases to follow.
The Ferraro Law Firm handles medical malpractice claims as a result of defective medical products or dangerous pharmaceuticals. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami and Washington, D.C.
28 attorneys general ask FDA to reconsider approval of Zohydro, Dec. 11, 2013, By John Fauber, Milwaukee Journal Sentinel
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