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U.S. Department of Health and Human Services

Safety

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Abilify (aripiprazole)

Audience: Neuropsychiatric healthcare professionals

FDA and Bristol-Myers Squibb notified healthcare professionals of revision to the WARNINGS section of labeling, describing the risk of hyperglycemia and diabetes in patients taking Abilify. FDA asked all manufacturers of atypical antipsychotic medications, including Bristol-Myers Squibb, to add this Warning statement to labeling.

[March 25, 2004 - Letter - FDA]
[March, 2004 - Revised label - Bristol-Myers Squibb]