Wednesday, May 25, 2011

Zyprexa : FDA issues limited Zyprexa warning information

In November 2001, the Journal of the American Medical Association medical officers from the FDA’s Center for Drug Evaluation and Research and a Duke University Medical Center physician first reported a possible link between Zyprexa and hyperglycemia in adolescents. Other FDA staff members then published a report in a December 2001 American Journal of Medicine linking Zyprexa to diabetes. Both Zyprexa reports used information from the FDA’s adverse drug reaction database.
The FDA has identified at least 384 reports of diabetes because of Zyprexa use, with the majority of cases appearing with six months of the start date. The Japanese Ministry of Health, Labor and Welfare, as well as the British medical equivalent to the FDA received reports of serious hyperglycemia and diabetes amongst Zyprexa patients and issued warnings accordingly. In the U.S., no such action was taken to warn physicians and patients of Zyprexa 
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