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Alzheimer News 10/18/2005
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Antipsychotic drugs linked to risk of death

Atypical antipsychotic drugs slightly increase an older person's risk of dying when used to treat agitation, aggression, restlessness, delusions and other behavioral symptoms of dementia, according to a report in the Oct. 19 issue of JAMA.

"Atypical" antipsychotics are second-generation drugs such as risperidone (Risperdal) and quetiapine (Seroquel), approved by the U.S. Food and Drug Administration (FDA) within the last decade to treat symptoms of schizophrenia, manic depression and other serious mental illnesses.

"This latest research adds to concerns about increased mortality raised by earlier studies," says William H. Thies, Ph.D., Alzheimer's Association vice president, medical and scientific affairs. "Research has also shown that the benefit of these drugs in dementia is usually modest. This study is a call to thoroughly analyze the risks and benefits of prescribing such drugs for any older adult with dementia. These medications still have a place in treating behavioral symptoms under some circumstances, but the decision to use them needs to be very thoughtfully considered and carefully tailored to the situation."

Earlier reports of a slightly increased risk of death led the FDA in April 2005 to add a "black box" warning about use of these drugs in dementia to the packaging. The warning, the strongest level required by the FDA, emphasizes that these drugs were never approved to treat dementia. Many drugs are commonly prescribed for purposes other than the conditions for which they were originally approved. This practice is called "off-label" prescribing.

This study is a meta-analysis, a type of research that assembles data from a group of individual studies that meet certain criteria for inclusion and then uses advanced statistical techniques to reveal patterns that may not emerge from any one study. In this case, the increased risk of death was not apparent in any of the 15 individual drug trials. When the researchers analyzed all the studies together, however, the risk was statistically significant and was seen with all the atypical antipsychotic drugs commonly prescribed in the United States.

Two of the individual studies involved haloperidol (Haldol), an older "first-generation" antipsychotic drug. There was a similar degree of increased risk of death associated with Haldol, but that risk did not reach statistical significance.

The actual increase in risk was about 1 percent, which would mean one death might occur for every 100 individuals treated with an atypical antipsychotic drug. The researchers point out that since most of the drug trials included in the study lasted only 8 to 12 weeks, the risk might increase more with longer treatment.

Nine of the 15 studies considered in the meta-analysis were never published in professional journals. To obtain data from these unpublished studies, the researchers searched conference programs, abstract books, and Web postings about scientific meetings. The scientists followed up preliminary information gleaned from these sources by requesting further details from trial sponsors.

For more information:

  • Alzheimer's Association fact sheet on treating behavioral and psychiatric symptoms of dementia

  • Alzheimer's Association April 2005 research news story on the FDA's "black box" warning on use of atypical antipsychotics in dementia: www.alz.org


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Formed in 1980, the Alzheimer's Association is the leading voluntary health organization in Alzheimer's care, support and research.