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FDA Raises Safety Concerns About Potential Fibromyalgia Drug

Wall Street Journal reports that the FDA revealed safety concerns about Jazz Pharmaceuticals Inc.’s potential fibromyalgia drug Rekinla (sodium oxybate), which faces a review on Friday from the FDA’s arthritis and drug-safety advisory committees. The drug is currently approved to treat narcolepsy under the brand name Vyrem, but would be dosed in a different way to treat fibromyalgia. Jazz also is proposing to sell the drug under a different restricted distribution program than currently used for narcolepsy, which would involve 15 specialty pharmacies, but the FDA said that two restricted distribution programs may create confusion among prescribers and be burdensome to the healthcare system. The FDA also said it was concerned about having two different brand names for the drug.

However, the AP reports that the FDA said the drug “effectively treated pain from fibromyalgia in two company-run studies,” though “regulators have concerns about the misuse and abuse of the drug, which has been used as an illegal stimulant and a date rape drug.” FDA reviewers also “cautioned that an approval for fibromyalgia would greatly expand the drug’s patient population, making it harder to control.”

Bloomberg News adds that according to a Jazz-sponsored study published last year in the Journal of Clinical Sleep Medicine, “Ten cases of abuse occurred among the 26,000 narcolepsy patients worldwide who received Xyrem from 2002 to 2008,” and the drug “also was linked to one death and two cases of sexual assault.” Reuters and NPR also cover the story.

From the American Association for Justice news release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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