FDA to add Boxed Warnings to conventional antipsychotics

The US Food and Drug Administration has issued letters to the manufacturers of "conventional" antipsychotic drugs requesting a Boxed Warning be added to the label of the products over fears of an increased risk of death associated with their off-label use in the treatment of behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the agency's strongest, were added. The FDA warning will now appear on both classes of drug, under the enforcement of the new Food and Drug Administration Amendments Act of 2007.

Recently, two observational epidemiological studies compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. According to the FDA, these studies have limitations that preclude reaching a definitive conclusion about comparative death rates. Nevertheless, the agency has provided the following advice to health care professionals: