FDA Warns of Unapproved Antipsychotic Use By Elderly

By Ramsay Crooks

Published on July 24, 2005

The drugs in question, approved only for treatment of such conditions as schizophrenia and mania, include Zyprexa (olanzapine), Clozaril (clozapine), Risperdal (risperidone), Abilify (aripiprazole), Seroquel (quetiapine), and Geodon (ziprasidone). Clinical studies have shown that when treatment for dementia with these drugs, older people have a higher death rate than in a group of similar patients who were taking a placebo.

The FDA has requested that manufacturers of these drugs warn against such off-label, or unapproved, use by adding a boxed warning to the label, clearly noting that the drugs should not be used to treat behavioral problems in older people with dementia.

Elderly people who are currently taking any of these drugs to treat dementia should work with their health care providers to determine the best course of action.

Also under scrutiny are older generations of antipsychotic drugs and their effect on older people. The FDA is reviewing their latest data to determine whether a similar warning is called for on these older drugs.

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