Week of July 6 - July 12, 2008

A pharmacist fills a prescription for antipsychotic medication.

The New York Times recently examined the growing use of antipsychotic drugs to lessen "the agitation, combative behavior and outbursts" of dementia patients.

Sales of newer antipsychotics -- including Risperdal, Seroquel and Zyprexa -- increased from $4 billion in 2000 to $13.1 billion in 2007. According to the Times, the increase in part can be attributed to prescriptions at nursing homes. Researchers estimate that about one-third of all nursing home patients have been given antipsychotics. While FDA has not approved these drugs for the treatment of dementia, they are frequently prescribed "off-label," according to the Times.

The Times reports that because many nursing homes are short-staffed and insurers do not generally pay for the "attentive medical care and hands-on psychosocial therapy that advocates recommend," it is "much easier" to use sedatives and antipsychotics on patients with dementia. According to the Times, many physicians say misuse of antipsychotics is common. "These antipsychotics can be overused and abused," and "there's a lot of abuse going on in a lot of these places," Johnny Matson, a professor of psychology at Louisiana State University, said. Dillip Jeste, a professor of psychiatry and neuroscience at the University of California-San Diego, said if elderly patients are prescribed these drugs, it should be in a very low dose for the shortest time possible.

State Lawsuits
The Times reports several states have filed lawsuits against leading manufacturers of antipsychotics, alleging the companies have used false or misleading marketing. Ambre Morley, a spokesperson for Janssen, the Johnson & Johnson subsidiary that makes Risperdal, said, "As with any medication, the prescribing of a medication is up to a physician." She added, "We only promote our products for FDA-approved indications."

No Benefit, Increased Risk
A 2006 study showed that for most Alzheimer's disease patients, antipsychotics resulted in no significant improvement over placebos in treating aggression and delusions. In addition, in 2005, FDA mandated that the newer antipsychotics carry a "black box" warning label cautioning patients of an increased risk of death. Meanwhile, FDA last week required that older antipsychotics also include a "black box" warning of increased risk of death.

Different Strategies
Some nursing homes are trying an approach called environmental intervention, which includes reducing boredom; providing intellectual and physical stimulation; exercising; playing calming music; bringing in pets for therapy; and improving how staff members talk to elderly patients. In addition, another group of anti-dementia treatments -- including Pfizer and Eisai's Aricept, the Exalon patch and Menamda -- show noticeable positive improvement in 10% to 20% of Alzheimer's patients, with 40% more showing some cognitive improvement, experts say.

Meanwhile, some physicians say that "simply paying attention" to patients with dementia can help ease symptoms, according to the Times. Those physicians note that in randomized trials of antipsychotic medications, 30% to 60% of participants in the placebo group improved .

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Reprinted from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at www.kaisernetwork.org/dailyreports/healthpolicy . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Reviewed for medical accuracy by
Dr. Boaz Ancselovic, MD, Geriatrician, Alzheimer's Weekly

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© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.