April 12, 2005

FDA Warning - Alzheimers /Antipsychotics

FDA Warning on Antipsychotic Drugs for Elderly suffering from Dementia

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 FDA's warning specifically related to atypical antipsychotic drugs that are approved for the treatment of mania and schizophrenia. 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.

More Information On the Net:

   FDA advisory/Warning on Anti-Psychotics


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