Atypical Antipsychotic Warnings Lowered Elderly Prescriptions: Study

The misuse of powerful atypical antipsychotics for the treatment of dementia, which may increase the risk of death, has taken a sharp downturn following recent FDA warnings, according to the findings of a new study. 

The use of drugs such a Seroquel, Risperdal, Zyprexa and other atypical antipsychotics have fallen by about a third since the FDA placed a “black box” warning on the medications urging doctors and nursing homes not to use them to treat dementia patients.

A “black box” warning, which is featured prominently on the label in a bold box, is the strongest warning that can be placed on a prescription medication.

The powerful psychotropic drugs are not approved for treatment of dementia, may increase the risk of death for dementia patients and many experts say that they do nothing to actually treat dementia. However, atypical antipsychotics have been widely used “off-label,” especially in nursing homes and among the elderly.

Some have suggested that much of that use was a form of nursing home “chemical restraint,” acting as a means of subduing elderly residents who are difficult to manage or care for. Prior studies have suggested that antipsychotic drugs were widely misused in nursing homes, with many residents receiving the medications when they had no medical condition that required such treatment.

According to the findings of this new study, which was published in this month’s issue of the Archives of General Psychiatry, the overall use of new and old antipsychotic drugs in elderly patients with dementia dropped from almost 18% in 1999 to about 12% in 2007; a decline of about a third. The researchers noted that the use of older antipsychotics had already been on the decline, but until the FDA warning, the use of newer atypical antipsychotics, such as Seroquel, Risperdal and Zyprexa, had been on the rise for dementia patients.

In recent years, a number of atypical antipsychotic drug makers have gotten into legal trouble over their aggressive promotion of the drugs for a variety of uses that were never approved by the FDA.

In 2009, Pfizer agreed to pay the largest criminal fine in U.S. history, $1.195 billion, to resolve claims that it illegally promoted the atypical antipsychotic Geodon, along with a number of other drugs.

In October 2010, a Louisiana jury issued a $257.7 million award against Johnson & Johnson for giving doctors misleading information about the risks and benefits of Risperdal. The company also faces a whistleblower lawsuit backed by the federal government that accuses it of paying kickbacks to Omnicare, a nursing home pharmacy supplier, to push the drug onto elderly patients.