Risperidone Associated With Increased Risk of Hyperglycemia, Diabetes

Yael Waknine

Disclosures

August 05, 2004

Aug. 5, 2004 — The U.S. Food and Drug Administration (FDA) and Janssen have notified healthcare professionals of revisions to the warnings section of drug labeling for risperidone (Risperdal) via a revised version of the November 2003 letter, according to an alert yesterday from MedWatch, the FDA's adverse event and safety information reporting system. The warning refers to the increased risk of hyperglycemia and diabetes in patients treated with risperidone and other atypical antipsychotics.

The FDA has received reports of hyperglycemia, in some cases extreme and associated with ketoacidosis, in patients treated with these medications. Some cases of hyperglycemia have resolved upon discontinuation of the atypical antipsychotic while others have required continued antidiabetic treatment.

According to the letter, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events may be confounded by possible increased risk of diabetes mellitus (DM) in the schizophrenic population and increasing incidence in the general population. However, epidemiologic studies suggest an increased risk of transient-emergent hyperglycemia-related events in these patients.

The FDA recommends that all patients treated with atypical antipsychotics be monitored for symptoms of hyperglycemia and undergo fasting blood glucose testing upon presentation. Patients diagnosed with DM should be monitored regularly for loss of glucose control. Patients with traditional DM risk factors should undergo fasting blood glucose testing at initiation of treatment with atypical antipsychotics.

Additional information may be obtained by calling Janssen Medical Affairs at 1-800-JANSSEN. Serious adverse events should be reported to Janssen at the number above or to the FDA by phone (1-800-FDA-0188), by fax (1-800-FDA-0178), or online (http://www.fda.gov/MedWatch).

Reviewed by Gary D. Vogin, MD

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