MONDAY, April 11, 2005 (HealthDay News) --
The U.S. Food and Drug Administration warned Monday that "off-label" -- unapproved -- use of certain drugs used to treat behavioral disorders such as schizophrenia can be potentially fatal to elderly patients with dementia.
The drugs, called "atypical antipsychotic drugs," are approved for the treatment of mania and schizophrenia. But clinical studies of these drugs to treat behavioral disorders in elderly patients with dementia have shown a higher death rate linked with their use, compared to patients receiving a placebo, the FDA said.
In its warning, the FDA cited 17 placebo-controlled trials of olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), or quetiapine (Seroquel) in elderly patients with dementia who also had behavioral disorders. Fifteen of those trials, which included more than 5,106 patients, found a 1.6- to 1.7-fold increase in mortality. Most of the deaths were due to either "heart-related events" (heart failure, sudden death) or infections, primarily pneumonia, the agency said.
The FDA said it is requesting that the manufacturers of all these kinds of drugs add a boxed warning to their drug labeling, describing this risk and noting that these drugs are not approved for the treatment of behavioral disorders in elderly patients with dementia. Elderly patients taking these drugs for treatment of behavioral disorders associated with dementia should have their treatment reviewed by their health-care providers, the agency said.
The atypical antipsychotics fall into three drug classes based on their chemical structure. Because the increase in mortality was seen with atypical antipsychotic drugs in all three chemical classes, the FDA said it has concluded the effect is probably related to the "common pharmacologic effects of all atypical antipsychotic medications, including those that have not been systematically studied in the dementia population."
In addition to the drugs that were studied, the atypical antipsychotic medications include clozapine (Clozaril) and ziprasidone (Geodon). All of the atypical antipsychotics are approved for the treatment of schizophrenia. But none is approved for the treatment of behavioral disorders in patients with dementia.
Symbyax, a combination product containing olanzapine and fluoxetine, approved for the treatment of depressive episodes associated with bipolar disorder, will also be included in the request for a boxed warning, the FDA said.
The FDA said it is also considering adding a similar warning to the labeling for older antipsychotic drugs because the limited data available suggest a similar increase in mortality for these drugs.
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