Hyperglycemia, Diabetes Risks Added to Warning Label of Abilify

Yael Waknine

Disclosures

April 13, 2004

April 13, 2004 — Bristol-Myers Squibb has notified healthcare professionals of a revision to the warnings section of labeling for aripiprazole (Abilify), describing the potential increased risk of hyperglycemia and diabetes in patients taking the drug.

The U.S. Food and Drug Administration (FDA) has asked all manufacturers of atypical antipsychotic medications, including Bristol-Myers Squibb, to add this warning statement to drug labeling, according to Medwatch, the FDA's safety information and adverse event reporting program.

The FDA based its labeling change decision on a review of recent data related to the use of atypical antipsychotics and hyperglycemia. According to a letter to clinicians from Bristol-Myers Squibb, aripiprazole was not yet marketed at the time of the epidemiological studies and therefore was not included.

Bristol-Myers Squibb acknowledges in the letter the need for additional information, adding that there have been few reports of hyperglycemia and a review of the aripiprazole database revealed no increase in diabetes.

The FDA recommends that patients starting on atypical antipsychotic drugs be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes should undergo fasting blood glucose testing at the beginning of treatment and periodically thereafter to mitigate the risk of developing serious metabolic complications.

All patients receiving atypical antipsychotics should be monitored for symptoms of hyperglycemia (polydipsia, polyuria, polyphagia, and weakness). Those developing these symptoms during treatment should undergo fasting blood glucose testing.

Healthcare professionals should report all serious adverse events to the FDA MedWatch program at 1-800-332-1088, by fax at 1-800-332-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 30867, or via the Internet at http://www.accessdata.FDA.gov/scripts/medwatch.

Additional information about aripiprazole is available from Bristol-Myers Squibb at 1-800-321-1335 from 9 am to 5 pm EST, Monday through Friday.

Reviewed by Gary D. Vogin, MD

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