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June 14, 2009
FDA says three atypical antipsychotic medications may be effective in children, but carry risks
The Wall Street Journal (6/5, Dooren) reported that on June 5, staff from the Food and Drug Administration (FDA) said that three medications "currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry significant risks."
On June 9-10, "an FDA panel of outside medical experts is scheduled to meet to discuss" these atypical antipsychotics, and will be "asked to vote on whether each product is safe and effective for children ages 10 to 17."
According to the agency and the pharmaceutical makers, "studies showed the products were effective at treating the symptoms of bipolar and schizophrenia," but "all had side effects," including "sedation and weight gain."
The AP (6/6, Perrone) added that the "FDA released its review of the three drugs ahead of a meeting Tuesday where outside experts will weigh in on the" medications' "risks and benefits." On Friday, "FDA reviewers said...they were wary of exposing youngsters to the" medicines' "side effects, including weight gain and high blood sugar, 'because they may be exposed for many decades.'"
In the Wall Street Journal (6/5) Health Blog, Shirley S. Wang observed, "Recent studies of effectiveness have shown that the antipsychotics aren't as good as previously believed." In an email to the Health Blog, Thomas Insel, MD, director of the National Institute of Mental Health, wrote, "They reduce some symptoms for some people, but they help too few people recover."
Dr. Insel went on to explain that "with current antipsychotics you risk either metabolic side effects or neurological side effects."
Posted by admin at June 14, 2009 12:43 PM