The new warning has been adopted to address a finding of increased risk of death in some elderly people with dementia who are being treated with these drugs.
US FDA Expands Antipsychotic Drug Warning
The older anti-psychotic drugs received the warning after two observational studies indicated the drugs also had an increased risk of death associated with them when used to treat elderly patients with dementia.
Dr. Thomas Laughren, the director of the FDA's division of psychiatry drugs, told reporters the older, anti-psychotic drugs are only now receiving the black box warning because previously there had not been enough data.
In the studies, researchers found patients taking the older drugs had a 4.5 percent risk of dying, compared with patients on a placebo whose risk was 2.6 percent, Laughren said. He noted, however, that the patients in the study were elderly and many of them were already very ill, possibly resulting in biased findings.
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