Boxed Warning For Antipsychotics First Public Use Of FDA Labeling Authority
Executive Summary
FDA put its new labeling authority under the FDA Amendments Act on public display June 16 by directing makers of conventional antipsychotics to add to their drugs' prescribing information a boxed warning about use in elderly patients with dementia
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FDAAA Safety Labeling Powers Are Invoked Selectively But Leave Drugmakers Little Room To Maneuver
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Atypical antispychotics class warning
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