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Increased Mortality in Patients with Dementia-Related Psychosis

The FDA announced on April 11, 2005 that patients with dementia-related psychosis treated with atypical (second-generation) antipsychotic medications are at an increased risk of death compared to placebo. The medications associated with this risk include: olanzapine (Zyprexa®); aripiprazole (Abilify®); risperidone (Risperdal®); quetiapine (Seroquel®); clozapine (Clozaril®); ziprasidone (Geodon®); and olanzapine/fluoxetine (Symbax®). All of these agents are approved for the treatment of schizophrenia; however, none of the medications are approved for the treatment of behavioral disorders in patients with dementia. The FDA based this statement on a total of 17 placebo-controlled trials enrolling 5106 elderly patients treated with olanzapine, aripiprazole, risperidone and quetiapine. Fifteen of the studies showed an increased risk of death in the drug-treated patients between 1.6 to 1.7 times that seen in placebo-treated patients. The causes of death in the studies varied; however, most appeared to be either cardiovascular (heart failure, sudden death) or infectious (pneumonia) in nature.

Although clozapine, ziprasidone and olanzapine/fluoxetine were not systematically studied, the FDA has concluded that the effect is probably related to the common pharmacologic effects of all antipsychotic medications based on their chemical structures. The FDA is requesting the manufacturers of all atypical antipsychotics to modify their package insert with a boxed warning re-enforcing the lack of indication for treating dementia-related psychosis and describing the increased risk of death in elderly patients. The available data suggest a similar increase in mortality for the older antipsychotic medications; therefore, the FDA is also considering adding a similar warning to the labeling of these agents.

References:

1). www.fda.gov

2). Lexi-Comp Handheld Database. Lexi-Drugs (Comp + Specialties). Updated May 2005.

Julie LeRose, Pharm.D. Candidate