{"id":163,"date":"2011-09-23T16:51:52","date_gmt":"2011-09-23T16:51:52","guid":{"rendered":"https:\/\/blogs.nature.com\/spoonful\/2011\/09\/side-effects-of-antipsychotics-need-continued-monitoring-says-fda-committee.html"},"modified":"2011-09-23T16:51:52","modified_gmt":"2011-09-23T16:51:52","slug":"sideeffects_of_antipsychotics","status":"publish","type":"post","link":"https:\/\/blogs.nature.com\/spoonful\/2011\/09\/sideeffects_of_antipsychotics.html","title":{"rendered":"Side-effects of antipsychotics need continued monitoring, says FDA committee"},"content":{"rendered":"

Hormones aren\u2019t 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<\/a> the US Food and Drug Administration (FDA<\/span>). Many people are wringing their hands over whether children are being misdiagnosed<\/a> and, perhaps, unnecessarily medicated<\/a>. But there\u2019s another problem with the diagnosis spike: potential side effects from the antipsychotics doctors prescribe to treat the disorder.<\/p>\n

Yesterday, the FDA\u2019s Pediatric Advisory Committee reported<\/a> new data about the occurrence of obesity and diabetes in children taking antipsychotics. The report, presented by Tobias Gerhard<\/a>, 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<\/span>. 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\u2019s Abilify (aripiprazole), despite the finding of clinical equivalence.<\/p>\n

Yet even though the panel\u2019s report revealed no difference in side effect severity between the medicines, other studies have come to different conclusions. For example, a meta-analysis<\/a> published just last month found that some drugs had a greater effect than others, compared to placebo. For example, Eli Lilly\u2019s Zyprexa (olanzapine) was associated with greater weight gain than Abilify, AstraZeneca\u2019s Seroquel (quetiapine), or Janssen\u2019s Risperdal (risperidone). And children taking Zyprexa had the highest cholesterol of all studied antipsychotics, the study authors found.<\/p>\n

These conflicting results and the vague conclusion by the committee \u2014 to simply continue studying the side effects, as they similarly decided<\/a> back in 2009 \u2014 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<\/span> committee vote, Jeffrey Wagener<\/a>, a pediatric pulmonologist at the University of Colorado School of Medicine in Aurora, agrees. He voted against continued study because he doesn\u2019t think it\u2019s doing enough to confront the issue of metabolic side effects from antipsychotics in children and wants more action.<\/p>\n

\u201cI don\u2019t see how the FDA<\/span> is responding to the \u2026 request by this committee in a thorough fashion,\u201d he told Reuters<\/a><\/em>. \u201cIt\u2019s taken them two years to not respond to [the fact] that we need to be more than in the observational role.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

Hormones aren\u2019t 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\u2019s another problem with the diagnosis spike: potential side effects from the antipsychotics doctors prescribe to treat the disorder.  Read more<\/a> Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":128,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-163","post","type-post","status-publish","format-standard","hentry","category-drugs-drugs-and-more-drugs"],"_links":{"self":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts\/163","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/users\/128"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/comments?post=163"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts\/163\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/media?parent=163"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/categories?post=163"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/tags?post=163"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}