Side-effects of antipsychotics need continued monitoring, says FDA committee

Hormones aren’t the only excuse for teenage moodiness anymore: psychiatrists are increasingly diagnosing adolescents with bipolar disorder, with 65% more prescriptions and 35% more patients between 2002 and 2009, according to the US Food and Drug Administration (FDA). Many people are wringing their hands over whether children are being misdiagnosed and, perhaps, unnecessarily medicated. But there’s another problem with the diagnosis spike: potential side effects from the antipsychotics doctors prescribe to treat the disorder.

Yesterday, the FDA’s Pediatric Advisory Committee reported new data about the occurrence of obesity and diabetes in children taking antipsychotics. The report, presented by Tobias Gerhard, an epidemiologist at Rutgers University in New Brunswick, New Jersey, compared the development of obesity and diabetes in children and adolescents taking the five antipsychotics currently approved for pediatric use by the FDA. Although they found no difference in side effect occurrence among the various drugs, the committee voted to continue to study the issue, and to update the warning label on only one of the five antipsychotics approved for pediatric use, Bristol-Myers Squibb’s Abilify (aripiprazole), despite the finding of clinical equivalence.

Yet even though the panel’s report revealed no difference in side effect severity between the medicines, other studies have come to different conclusions. For example, a meta-analysis published just last month found that some drugs had a greater effect than others, compared to placebo. For example, Eli Lilly’s Zyprexa (olanzapine) was associated with greater weight gain than Abilify, AstraZeneca’s Seroquel (quetiapine), or Janssen’s Risperdal (risperidone). And children taking Zyprexa had the highest cholesterol of all studied antipsychotics, the study authors found.

These conflicting results and the vague conclusion by the committee — to simply continue studying the side effects, as they similarly decided back in 2009 — are a bit befuddling, as the question of negative antipsychotic side effects should warrant more significant action. And the single dissenter in the 16-1 FDA committee vote, Jeffrey Wagener, a pediatric pulmonologist at the University of Colorado School of Medicine in Aurora, agrees. He voted against continued study because he doesn’t think it’s doing enough to confront the issue of metabolic side effects from antipsychotics in children and wants more action.

“I don’t see how the FDA is responding to the … request by this committee in a thorough fashion,” he told Reuters. “It’s taken them two years to not respond to [the fact] that we need to be more than in the observational role.”

Leave a Reply

Your email address will not be published. Required fields are marked *