Further Study Of Antipsychotic Effects On Kids: FDA
2 CommentsBy Ed Silverman // December 4th, 2009 // 9:54 am
In advance of a meeting of the agency’s pediatric advisory committee meeting next week, staffers from the FDA’s Office of Pharmacovigilance are recommending further study the effects of atypical antipsychotic medicines in children. They made their suggestion after reviewing a study of medical literature that found a direct link between the drugs and adverse metabolic effects in kids.
The drugs cited are Lilly’s Zyprexa and AstraZeneca’s Seroquel, and the metabolic effects include abnormal weight gain and increases in cholesterol and blood pressure. The findings “by themselves may not reflect true agent-specific differences in risk,” the staffers wrote in an Oct. 14 report. They acknowledged “observational studies have limitations,” but also wrote “this hypothesis should, nonetheless, be subject to some further evaluation by the agency.”
The reviewers recommended the Seroquel data undergo further review as has already been done for Zyprexa. Meanwhile, AstraZeneca announced this morning that the FDA approved Seroquel for treating schizophrenia in 13-to-17 year olds as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents between 10 and 17 years old (see here).
Lisa Van Syckel
This is one, Big, Fat Joke!! Unfortunately, its the kids who will suffer the most.
talbot
If anything ever looked like an inside deal, this is it.