More proof that FDA warnings make a difference: Alerts about the risks of antipsychotic drugs appear to have depressed sales by some 19 percent, a new Archives of Internal Medicine study finds. "We concluded that it resulted in a modest reduction," researcher Dr. Ray Dorsey of the University of Rochester Medical Center says. Why modest? In part because antipsychotic scrips still accounted for 9 percent of prescriptions in the elderly in 2008.
Studies have shown that atypical antipsychotics--which include such best-selling drugs as Eli Lilly's Zyprexa and Johnson & Johnson's Risperdal--carry various safety risks, and the FDA has added strong warnings to the drugs' labeling. This study looks at a warning that the atypicals boost the risk of death in elderly people with dementia; that "black box" was added to the meds in 2005.
The researchers analyzed data on the use of those drugs from January 2003 to December 2008, finding that 19 percent decline in sales. But the group didn't have data on how many people might have benefited from the warning, Reuters reports. Nor did the researchers want to characterize the FDA's warning as a success or failure. "It's hard to say whether 20 percent is the right number," Dorsey tells the news service.
A commentary accompanying the study, however, posits that regulatory warnings about the atypical antipsychotics have had little effect on prescription numbers. "There's a real disconnect between the evidence and the prescribing patterns," co-author Becky A. Briesacher, associate professor at the University of Massachusetts Medical School in Worcester, tells HealthDay. Some geriatric doctors said that sometimes the benefits outweigh those risks. "The only medications that have been shown to work are antipsychotics, but the problem is they have side effects," says Dr. Davangere Devanand of the New York State Psychiatric Institute. "It's a balance."