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Antipsychotics Offer Modest Benefits for Non-Approved Conditions

Study Examines Risks and Benefits of Drugs Used for Conditions Not Specifically Approved by FDA

Measuring Benefits and Harms continued...

For symptoms of agitation associated with dementia, for example, researchers found patients treated with certain atypical antipsychotics saw about a 35% improvement in their symptoms. Trials of these medications for generalized anxiety disorder and obsessive-compulsive disorder found similar degrees of improvement.

But the review also found significant risks associated with taking the drugs.

The researchers found that elderly patients with dementia who took atypical antipsychotics had an increased risk of death compared to those who were taking a placebo.

In an analysis of 15 studies, 3.5% of elderly patients with dementia on atypical antipsychotics died compared to 2.3% in the placebo group.

That represents one extra death for every 87 elderly patients with dementia who take the drugs, researchers say.

Side effects in elderly patients from some or all of the atypical antipsychotics included significant risks of sedation, heart problems, involuntary movements, and urinary tract infections.

In younger adults, some or all of the drugs were associated with increased appetite and weight gain, sedation, fatigue, involuntary movements, and restlessness.

The bottom line, researchers say, is that these powerful medications should be used off-label only as a last resort.

"If there is something on-label that can be used, obviously you'd rather do that first, particularly with these medications because they do have significant side effects," Maher says.

Researchers say they hope the review will better inform doctors and patients who are considering using one of these drugs.

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