FDA Adds Metabolic Warnings to Fanapt

The U.S. Food and Drug Administration has enacted a major change to the "Warnings and Precautions" portion of the prescribing information for the atypical antipsychotic Fanapt (iloperidone). The label now includes information about the metabolic changes associated with atypical antipsychotic drugs that may increase cardiovascular and cerebrovascular risk. These changes include hyperglycemia, dyslipidemia, and weight gain. The revised label is posted at http://www.pharma.us.novartis.com/product/pi/pdf/fanapt.pdf. Fanapt was approved by the FDA in 2009 for the treatment of schizophrenia after initially being turned down. Read more about it in Psychiatric News here.

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