Jennifer Corbett Dooren
The Wall Street Journal
December 8, 2009

WASHINGTON (Dow Jones)–A top Food and Drug Administration official said Tuesday the agency is considering strengthening the labels of antipsychotic drugs to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults.

Thomas Laughren, the director of FDA’s division of psychiatric products, said the agency has asked manufacturers of drugs like Seroquel, Abilify and Zyprexa for all of the information they have 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.

While the labels of the drugs already discuss weight gain and its associated problems, Laughren said the agency is considering putting all the information in the warnings section, which would amount to a strengthening of the warning.

Laughren made his comments Tuesday at a pediatric advisory committee meeting which was reviewing the safety of several drugs used in children, including antipsychotics.

Laughren said the labels for AstraZeneca PLC’s (AZN) Seroquel and Eli Lilly & Co.’s (LLY) Zyprexa were already changed last week when the agency 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.

The drugs are used to treat a variety of mental illnesses, including bipolar disorder, schizophrenia and depression that doesn’t respond to other types of medication.

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 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. 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.

See article: http://online.wsj.com/article/BT-CO-20091208-714877.html