It's basically the same warning that has been carried on newer, atypical antipsychotic drugs since 2005. (See: FDA Warns of Excess Mortality to Elderly With Antipsychotics)
Thomas Laughren, M.D., director of the agency's psychiatry products division, said the move was prompted by two recent observational studies that found increased death rates with older antipsychotics, such as haloperidol (Haldol), chlorpromazine (Thorazine), and fluphenazine (Prolixin), in elderly patients with Alzheimer's disease and other advanced dementias.
Such patients may suffer delusions, hallucinations, and violent agitation, he said in a telephone news conference.
"It's a very difficult situation to manage clinically," he said.
Dr. Laughren emphasized that the label revision is a warning, not a contraindication. "We are not telling physicians they cannot use these drugs in this setting."
Earlier studies with atypical antipsychotics found a 1.6- to 1.7-fold increase in death rates compared with placebo among elderly patients with dementia-related psychosis.
"Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group," according to the warning now carried on atypical antipsychotics.
The new language, to be carried on both classes of drugs, includes:
"Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear."
Letters were sent today to manufacturers of all antipsychotic drugs with the new warning language, Dr. Laughren said.
He said the agency was comfortable that the warning was appropriate for conventional antipsychotics, despite the absence of controlled trials to confirm the excess mortality.