Dementia Drugs Tied to Deaths

Elderly patients with dementia were significantly more likely to die prematurely if taking certain antipsychotic drugs, the government said in an advisory Monday to healthcare workers and patients.

The Food and Drug Administration is asking manufacturers of atypical antipsychotic drugs to add to their labeling a boxed warning noting the risks and that the drugs were not approved to treat symptoms of dementia in the elderly.

Elderly patients taking the drugs for dementia-related symptoms should consult with their doctors, the FDA said.

The drugs were approved for treating schizophrenia and mania, and include such brands as Abilify, Zyprexa, Seroquel, Risperdal, Clozaril and Geodon. Symbyax, which is approved for the treatment of depression associated with bipolar disorder, is also included in the advisory.

An analysis of 17 studies covering four drugs showed the rate of death for the elderly patients taking them was about 1.6 to 1.7 times the rate of death for placebo users. The causes of death varied, but most seemed to be either heart-related or from infection.

The FDA doesn’t have data to indicate how many elderly patients take this class of drugs, but agency officials believe that such prescriptions are common.