Pain Drug With Date-Rape Chemical Is Safe, FDA Says
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Jazz Pharmaceuticals Inc.’s fibromyalgia drug is safe and effective, said U.S. regulators weighing whether to approve the medicine, which includes a chemical linked to date rape.
The treatment, JZP-6, reduced pain in clinical trials and its potential for side effects “appears to be acceptable,” Food and Drug Administration staff reviewers said in a report issued today. An FDA advisory panel will meet Aug. 20 to evaluate whether the drug’s benefits to patients with fibromyalgia, an illness that causes chronic muscle pain and fatigue, outweigh risks of abuse and accidental overdose. Jazz sells the drug, known chemically as sodium oxybate, under the name Xyrem for people with narcolepsy, a sleep disorder.