Jazz Gets Warning Letter for Minimizing Risks of Schizophrenia Drug in Patient Promo

Jazz Pharmaceuticals received an FDA warning letter for overstating the benefits and minimizing or omitting the risks of its schizophrenia drug FazaClo in a patient brochure. The DTC ad for FazaClo (clozapine, USP) orally disintegrating tablets strays from the product’s prescribing information (PI), the agency said in the recently posted letter. The drug’s PI leads with a boxed warning about its “significant risk” of agranulocytosis, an acute condition that can lower infection-fighting white blood cell counts. It states that agranulocytosis is “potentially life-threatening adverse event,” but the FazaClo brochure does not, the FDA said.
Drug Industry Daily