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Widely prescribed anti-psychotic drugs do not help most Alzheimer's patients with delusions and aggression and are not worth the risk of sudden death and other side effects, the first major study on sufferers outside nursing homes concludes.

The study tested Zyprexa, Risperdal and Seroquel—newer drugs developed for schizophrenia. Doctors are free to prescribe them for any use. However, the drugs carry a strong warning that they increase the risk of death for elderly people with dementia-related psychotic symptoms, mainly because of heart problems and pneumonia, and that they are not approved for such patients.

Older patients with dementia who are given antipsychotic medicines are far more likely to die prematurely than those given dummy pills, federal drug regulators said Monday. The warning adds to growing worries about the safety of the widely prescribed drugs.

The Food and Drug Administration said that it would now require manufacturers of the medicines to place black-box warnings—the agency's most severe—on the labels of all the drugs. In 2003, the agency required manufacturers to add a warning about an increased risk of diabetes from antipsychotic medications.

Three drugs commonly prescribed for schizophrenia and other psychotic illnesses increased patients' risk of
developing diabetes when compared with older antipsychotic medications, researchers said yesterday,
presenting the results from a long-awaited study of patients treated at veterans hospitals and clinics across the
country.

The drugs—Zyprexa, made by Eli Lilly, Risperdal, made by Jannsen Pharmaceutica, and Seroquel, made by
AstraZeneca—were associated with higher rates of diabetes than older generation drugs for schizophrenia
like Haldol, the study found.