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Jazz Pharmaceuticals Didn’t Report Drug Side Effects, FDA Says

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The U.S. Food & Drug Administration (FDA) has released a warning letter to Jazz Pharmaceuticals Inc. over violations at a California plant.

The letter, dated Oct 11, cites the company for failing to record 74 reports of serious drug side effects or injuries. Federal regulations require companies to submit reports of 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 agency’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 in a statement.

The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing, marketing and testing. The letters are not legally binding, but the agency can take companies to court if they are ignored.

sideeffectslawsuitsnews.com disclaimer: This article: Jazz Pharmaceuticals Didn’t Report Drug Side Effects, FDA Says was posted on Wednesday, October 19th, 2011 at 4:17 pm at sideeffectslawsuitsnews.com and is filed under Uncategorized.

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