Off-Label Atypical Use: Few Benefits, Serious Adverse Effects

Off-label use of atypical antipsychotics may do more harm than good, a new meta-analysis suggests.

A combined analysis of more than 150 efficacy trials showed significant increases in behavioral symptom scores for dementia in the elderly after they were treated with aripiprazole, olanzapine, or risperidone; benefits for nonelderly patients with generalized anxiety disorder (GAD) after they received quetiapine; and benefits for patients with obsessive-compulsive disorder (OCD) after receiving risperidone augmentation.

However, analysis of more than 200 adverse outcome studies showed that treatment-related adverse events, including death, were common in these patient groups.

“Besides the small but statistically significant effect found for dementia, the other improvements were a bit smaller than we expected, with moderate effects for GAD and OCD,” lead author Alicia Ruelaz Maher, MD, psychiatrist at the Akasha Center for Integrative Medicine in Santa Monica, California, and assistant clinical professor in psychiatry at the University of California, Los Angeles, School of Medicine, told Medscape Medical News.

“As for the other conditions that these medications commonly treat, we just did not find enough of an effect. And despite olanzapine being known to cause weight gain, I was surprised to find it was not effective in causing weight gain in eating disorders,” said Dr. Maher, who is also a clinical adjunct at the RAND Health Southern California Evidence-Based Practice Center in Santa Monica.

She noted that the study is the “largest study of its kind on this subject,” and prompted clinicians to reconsider the way they prescribe atypical antipsychotics.

“I think the biggest takeaway is that instead of just prescribing blindly, we now have evidence to guide us. There are certainly times when the cost-benefit analysis would go towards using medication, but I would hope that the side effects are kept in mind.”

The study appears in the September 28 issue of JAMA….

Reported by Deborah Brauser

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