Atypical antispychotics class warning
Executive Summary
FDA approves labeling changes Aug. 14 to provide atypical antipsychotics with consistent language warning against their use in elderly patients with dementia-related psychosis. Lilly's Zyprexa and Symbyax, Bristol-Myers Squibb/Otsuka's Abilify, Johnson & Johnson's Risperdal and Invega, AstraZeneca's Seroquel, Novartis' Clozaril and Pfizer's Geodon are all subject to the changes, which were ordered under new FDA Amendments Act authority (1"The Pink Sheet," June 23, 2008, p. 19). The boxed warning for the drugs now includes a statement that, similar to atypical antipsychotics, treatment with conventional antipsychotics also may increase mortality, and that it is unclear whether increased mortality is attributable to the drugs or a characteristic of the patients
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