As a condition of approval, the Food and Drug Administration required the manufacturer of Xyrem (sodium oxybate; Jazz Pharmaceuticals, Inc., Palo Alto, CA) to establish and maintain a risk management program. Required elements of this program include the use of a single central pharmacy to ship sodium oxybate directly to patients and gather adverse event (AE) data including deaths which are reported to the FDA. The results of a post-marketing safety study1 indicated 30 fatalities had occurred in patients prescribed sodium oxybate from 2002 through early 2008, although most were determined to be unrelated to the medication.
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