FDA Warning Letter Faults Brochure For Schizophrenia Treatment FazaClo

The Food and Drug Administration told Jazz Pharmaceuticals Inc. that a patient brochure for FazaClo (clozapine) is false or misleading because it omits and minimizes important risk information associated with the drug, broadens the approved indication, presents unsubstantiated superiority claims, and overstates the drug’s efficacy, according to a warning letter posted Sept. 19 on FDA’s website.

FazaClo, an orally disintegrating tablet, is indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia, the agency said. Because of the significant risk of agranulocytosis and seizure associated with its use, FazaClo only ...