FDA Ignores Medical Board and Approves Painkiller with Potential of Abuse

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The FDA has totally ignored the 11-2 disapproval of its medical advisory board and proceeded to approve Zohydro, a drug, which even during tests compelled one of the test subjects to commit suicide from overdosing and hoarding the drug. Zohydro is alleged to contain 5-10 times more of hydrocodon than Vicodin, and the extended release opiate is undiluted.

Significantly, it also does not contain the gel, now standard in OxyContin, that prevents the tablets from being crushed and snorted.

  

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During the December hearing on the drug last year, Avi Israel, the dad of a 20-year-old who committed suicide after hydrocodone addiction, said, “If you approve this pill, you surely will be signing a death sentence for thousands of people, especially young kids.”

But that was the personal opinion of a father who lost his son to painkiller addiction.

The FDA’s advisory board, however, was of the same opinion, and ruled 11-2 against approving the drug.

One of the main reasons for going against approval of the drug, from the point of the advisory board, was that Zohydro did not dilute its opiate with acetaminophen, but, like OxyContin, provided the undiluted form.

The medical advisers warned that this could lead to greater possibility of addiction and abuse.

But that is probably the personal 11-2 opinion of the advisory board to not approve a money-making machine.

The FDA knows better and has gone on to approve the drug.

Liscinsky, the FDA spokesperson admitted that out of the 575 test subjects given Zohydro, 5 had died. Out of the first four deaths, one was suicide, another was from drug toxicity from other painkillers (not Zohydro), and one death was an “apparent suicide” by a patient who “hoarded study medication” and died a year after the study was over from an overdose.

However, be ready to now buy Zohydro over the counter, as the FDA has approved it.

Licinsky told Mother Jones, the publication, “FDA has concluded that the benefits of Zohydro ER outweigh its risks …”