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2004 Safety Alert: Risperdal (risperidone) |
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The following information is from Janssen Pharmaceutica, Inc. Contact the company for a copy of any referenced enclosures.Dear Health Care Provider, Janssen Pharmaceutica, Inc. would like to inform you of important labeling changes regarding Risperdal ® (risperidone). The FDA has asked all manufacturers of atypical antipsychotic medications, including Janssen Pharmaceutica, Inc. to add a Warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including Risperdal. Accordingly, the Risperdal Prescribing Information has been updated with the addition of the following information: WARNINGS Hyperglycemia and Diabetes Mellitus Patients with risk factors for diabetes mellitus (eg, obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug. If you have any questions regarding this important safety information, please contact Janssen Medical Affairs at 1-800-JANSSEN. Please refer to the full prescribing information for RISPERDAL included with this letter. As always, we request that serious adverse events be report to Janssen at 1-800-JANSSEN or to the FDA MedWatch program by phone (1-800-FDA-0188), by fax (1-800-FDA-0178), or by e-mail (www.fda.gov/medwatch). Sincerely, Ramy A. Mahmoud, MD, MPH |
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