First Generation and Newer Classes of Antipsychotic Medications May Increase Risk of Death Among Elderly
FDA black box warnings should also include first-generation medications
Boston – Among Americans age 65 and older, antipsychotic medications are widely used for a variety of disorders including dementia, delirium, psychosis and agitation. Complicating this widespread use, in April 2005, the FDA issued a Public Health Advisory warning that newer or “atypical” antipsychotic medications nearly doubled the risk of death among elderly patients. The concern among researchers at Brigham and Women’s Hospital (BWH) is that this “black box” warning may be driving physicians to prescribe “first generation” or conventional antipsychotic drugs such as Thorazine or Haldol, because these older drugs were not included in the FDA warning due to insufficient data on them.
In this important study, BWH researchers found that patients prescribed conventional antipsychotic drugs had a 37 percent higher risk of death in the short term than among those to whom atypical medications were prescribed. Researchers now caution physicians to carefully evaluate the safety of simply swapping new for old medications. These findings are published in the December 1, 2005 issue of the New England Journal of Medicine.
According to lead author, BWH pharmacoepidemiologist Philip Wang, MD, DrPH, “Older Americans are an extremely vulnerable segment of the population with very specific health needs and risks. Studying the impact of antipsychotic medications on specifically these vulnerable individuals—and not just extrapolating from studies in younger populations as is often done— is important to help ensure that the elderly receive optimal care.”
In this study, researchers analyzed data from 22,890 patients, 65 years of age or older, who had drug insurance benefits in Pennsylvania and who began receiving conventional or atypical antipsychotic medication between 1994 and 2003. The researchers identified those given conventional antipsychotics (such as Haldol or Thorazine) and atypical drugs (such as Risperdal and Zyprexa). The researchers found that patients prescribed the older drugs had a 37 percent higher risk of death after starting the medication than those who were prescribed the newer medications. In the first 180 days of use, 17.9 percent of patients on conventional antipsychotic medications died as compared with 14.6 percent of those taking atypical agents. The greatest increase in risk of death among conventional versus atypical drug users occurred with higher doses and during the first 40 days after starting therapy.
“These results suggest that clinicians should not simply replace atypical agents that they stopped in response to the FDA warning, with the older drugs,” stated Wang, who is also an associate professor of Psychiatry at Harvard Medical School. “However beyond suggesting caution, our data provide no guidance on what treatments should be used to help manage the many conditions and symptoms that antipsychotics are used for—studies defining what optimal care is in the elderly are still sorely needed.”
Please contact BWH Media Relations for more information at (617) 534-1600 or BWHMediaRelations@partners.org
Brigham and Women's Hospital is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832 and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives, dedication to educating and training health care professionals, and strength in biomedical research. With $370M in funding and more than 500 research scientists, BWH is an acclaimed leader in clinical, basic and epidemiological investigation - including the landmark Nurses Health Study, Physicians Health Studies, and the Women's Health Initiative. For more information about BWH, please visit: www.brighamandwomens.org.
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