The FDA warning letter, dated Oct 11, cites the company for failing to report 74 reports of serious drug side effects or injuries. Federal regulations require companies to submit reports of so-called adverse events within 15 days of receiving them. The FDA listed several examples of reports involving patients taking Xyrem, a Jazz Pharmaceuticals drug used to treat excessive sleepiness. The unreported adverse events were received between January 2003 and December 2010.
FDA inspectors said the company had failed to develop written procedures for monitoring and submitting adverse reports to the FDA. The inspectors note that Jazz received a similar citation from the FDA in September 2007.
A statement, Palo Alto, Calif.-based Jazz Pharmaceuticals said it has been working "diligently" to address the FDA's concerns since April, when it first became aware of the situation. "We look forward to responding quickly to this warning letter and demonstrating our compliance to FDA's satisfaction," the company said.
Wednesday, October 19, 2011
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