The U.S. Food and Drug Administration (FDA) issued a Public Health Advisory today warning that the use of certain atypical antipsychotic medications in elderly patients suffering from dementia is associated with increased mortality in those patients. Over a total of 17 placebo-controlled trials performed with the drugs Zyprexa (olanzapine), Abilify(aripiprazole) , Risperdal (risperidone) and Seroquel (quetiapine), fifteen trials showed numerical increases in mortality in the drug-treated group compared to the group treated with a placebo. Several analyses of the trial results have demonstrated an approximately 1.6 to 1.7-fold increase in mortality in these patients. Most deaths were due to heart-related events such as heart attack, heart failure or sudden death, or infections such as pneumonia.

The FDA has concluded that the increased mortality effect is probably related to the common pharmacologic effects of all atypical antipsychotic medications, including those that have not been systematically studied. The atypical antipsychotic medications include Clozaril (clozapine), Geodon (ziprasidone), and the combination drug Symbyax (a combination of olanzapine and fluoxetine). All of the atypical antipsychotic medications are approved for the treatment of schizophrenia, but none are approved for the treatment of behavioral disorders in patients with dementia.

The findings prompted the agency to demand that the manufacturers of these drugs include a boxed warning in their labeling describing this risk to patients with dementia and that Zyprexa (olanzapine), Abilify(aripiprazole), Risperdal (risperidone), Seroquel (quetiapine), Clozaril, Geodon and Symbyax are not approved for the treatment of elderly dementia patients.