FDA Staff Recommends Look At Child Weight Gain With Antipsychotics

WASHINGTON (Dow Jones)–Food and Drug Administration medical reviewers said Friday the agency should conduct an additional review of antipsychotic drugs to look at the impact of weight gain in children, a common side effect of the drugs.

Labels for the drugs, which include AstraZeneca PLC’s (AZN) Seroquel and Eli Lilly & Co.’s (LLY) Zyprexa, already warn of increases in weight and other side effects, but the FDA said those warnings aren’t specific to younger patients. The drugs are used to treat a variety of mental illnesses including bipolar disorder, schizophrenia and depression.

The recommendation for additional study of the impact of weight gain in children came as the agency Friday officially approved the use of Zyprexa for use in children ages 13 to 17 and Seroquel for use in children as young as 10 to treat bipolar disorder and schizophrenia.

The drugs were previously approved for adult patients, but doctors routinely prescribed the products to younger patients. The label for Zyprexa suggests that doctors consider trying other treatments first because of the increased potential for weight gain and cholesterol in adolescents compared to adults, Eli Lilly said.

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.

The drugs–which also include Risperdal, made by a unit of Johnson & Johnson (JNJ); Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co.; and Pfizer Inc.’s (PFE) Geodon–are scheduled for a review by the FDA’s pediatric advisory panel next Tuesday. Antipsychotics were the top-selling drug class in the U.S. last year with $14.6 billion in sales, ahead of the $14.5 billion in sales of cholesterol drugs, according to IMS Health.

In a memo prepared for the meeting and posted Friday on the FDA’s Web site, agency medical reviewers cited another study published in 2008 that found antipsychotic drug use was associated with diabetes. That study looked at a health-maintenance organization’s drug-claim database and compared antipsychotic drug use and diabetes drug use. The study found a stronger association between antipsychotic drug use and diabetes in younger patients.

FDA staff reviewers said the findings are worthy of additional study with “robust clinical data.”

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Posted: 12/07/2009 at 06:43 AM
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Posted: 12/07/2009 at 06:43 AM
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