Antipsychotic Medications Harmful to Seniors

Armen Hareyan's picture

Here's a bitter pill to swallow: the U.S. Food and Drug Administration (FDA) has found that a certain group of psychiatric drugs can increase the risk of death in seniors suffering from dementia. As a result, the agency is warning doctors against prescribing the drugs.

The FDA's warning is a follow-up to a 2005 action, which mandated warnings about increased heart attacks and pneumonia in patients who take drugs called atypical antipsychotics. These drugs include Eli Lilly & Co.'s Zyprexa and Johnson & Johnson's Risperdal.

The agency reached its new decision after two studies of a combined 65,000 seniors showed those taking antipsychotic medications had a higher risk of death than those not taking the drugs.


Eleven older drugs, including Pfizer's Navane and Endo Pharmaceutical's Moban, called typical antipsychotics, pose the same risks, according to the FDA. The agency has called for both drug types to now carry box warnings describing their dangers to dementia patients.

"We've struggled with this decision but we ultimately decided the data are strong enough to expand this label to drugs in both classes," said Thomas Laughren, director of FDA's psychiatric drug division.

Antipsychotic drugs are permitted by the FDA to treat schizophrenia and bipolar disease. Despite warnings by federal officials, these drugs are still being prescribed "off-label," or for purposes that have not been approved by the FDA. According to information released by Medicare earlier this year, approximately 20 percent of seniors in nursing homes who receive these drugs have not been diagnosed with psychiatric problems.

The FDA said there is "no approved drug for the treatment of dementia-related psychosis" and advised doctors consider alternatives to the antipsychotic drugs.

Source: "Antipsychotic Drugs May Hurt In Dementia." The Pittsburgh Channel. June 17, 2008.