The use of antipsychotic drugs is common in the care of the elderly with dementia and associated behavioural problems, but until recently none of these agents had marketing authorisation for this indication. Medicines regulators have recognised this off-label use and issued warnings about the special risks posed to the elderly. The increased risk of stroke has been reflected in product information for five years, but recent attention has shifted to mortality risk. Initially confined to new-generation atypical antipsychotics in which an approximately 1.6–1.7-fold increase in mortality has been demonstrated, recent evidence points to a risk of at least similar magnitude with older-generation typical agents, prompting warnings by UK and US medicines regulators about an increased risk of death associated with the entire class, atypical and typical.
Declaration of Interests The author has had no involvement in any of the regulatory decisions reviewed.
