FDA May Strengthen Antipsychotic Labels For Kids
Make a commentBy Ed Silverman // December 9th, 2009 // 8:43 am
An FDA official says the agency is considering strengthening the labels to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults, Dow Jones writes.
Tom Laughren, who heads the FDA’s division of psychiatric products, says the agency asked drugmakers to provide all their info on metabolic side effects such as increases in blood glucose, which can cause diabetes, and blood cholesterol levels which can lead to cardiovascular problems over time.
The labels already mention weight gain and related problems, but Laughren says the FDA is considering putting all the info in the warnings section, which is tantamount to a stronger label. He made his comments yesterday at a pediatric advisory committee meeting held to review the safety of several drugs used in children, including antipsychotics.
Labels for AstraZeneca’s Seroquel and Lilly’s Zyprexa were already changed last week when the FDA approved the products for use in younger patients and, in Seroquel’s case, when it was approved as an add-on treatment for major depression. However, he said all of the drug labels in the class could change as the FDA continues its “comprehensive” review.
A study published last month in the Journal of the American Medical Association found the drugs caused children and adolescents to gain an average of 19 pounds in 11 weeks of treatment. The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.
In advance of the pediatric panel meeting, FDA staff recommended the agency should conduct an additional review of antipsychotic drugs to look at the impact of weight gain in children. Several studies have shown children and adolescents gain weight at a faster rate than adults. Other drugs in the class include Johnson & Johnson’s Risperdal; Bristol-Myers Squibb’s Abilify and Pfizer’s Geodon.
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Abilify, Antipschyotics, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Geodon, Johnson & Johnson, Pfizer, Risperdal, Seroquel, Thomas Laughren, Tom Laughren, Zyprexa