Study Questions 'Off-Label' Use of Antipsychotics

FRIDAY, Jan. 19 (HealthDay News) -- Newer antipsychotic medications are being used widely for a variety of psychiatric disorders for which they were not initially approved.

This "off label" use comes without strong evidence that the drugs are effective for these conditions and with a risk for serious side effects, said a report issued this week by the Agency for Healthcare Research and Quality (AHRQ).

The medications were approved to treat conditions such as schizophrenia and bipolar disorder, but are now being prescribed to millions of Americans for depression, dementia, and other psychiatric disorders without strong evidence that such off-label uses are effective, the report stated.

"The issue of off-label indications is a problem across medications, but I think it's particularly of concern with drugs that affect mental-health issues," said Dr. David Atkins, chief medical officer at AHRQ's Center for Outcomes and Evidence.

The revelation, contained in an AHRQ report titled Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics, was not startling to clinicians.

"The surprise is that people have not been more adamant about this earlier," said Dr. Julio Licinio, chairman of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine.

The report comes on the heels of another study that found that antipsychotic drugs, commonly prescribed to treat psychosis, agitation and aggression in Alzheimer's patients, are essentially no more effective than a sugar pill.

Atypical antipsychotics such as aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) and ziprasidone (Geodon) are designed to cause fewer neurological complications than older antipsychotics. They are approved to treat schizophrenia and bipolar disorder but are increasingly used to treat dementia, geriatric aggression, depression, obsessive-compulsive disorder, post-traumatic stress disorder and personality disorders.

Using the drugs "off label' for conditions other than their original approval is perfectly legal but causes concern among some experts. A 2001 report by the AHRQ concluded that about 21 percent of prescribed drug use was for conditions not indicated on the label.