FDA: Adult Antipsychotic Drugs Effective In Children

Food and Drug Administration staff said Friday three drugs currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry “significant risks.”

The agency is considering applications for AstraZeneca PLC’s (AZN) Seroquel and Eli Lilly and Co.‘s (LLY) Zyprexa to treat bipolar disorder and schizophrenia in children and adolescents, and Pfizer Inc.‘s (PFE) Geodon to treat bipolar disorder in children 10 to 17. An FDA panel of outside medical experts is scheduled to meet to discuss the drugs next Tuesday and Wednesday. The panel is being asked to vote on whether each product is safe and effective for children ages 10 to 17.

The FDA as well as the companies said studies showed the products were effective at treating the symptoms of bipolar and schizophrenia, but the drugs all had side effects that included sedation and weight gain. Reviews of the products were posted on FDA’s Web site Friday.

“These risks are of particular concern in pediatric patients because of the life-long nature of these disorders” said Thomas Laughren, director of the FDA’s psychiatric product division, in a memo.

The concern with weight gain seen with most antipsychotic drugs whether it causes additional problems like diabetes and cardiovascular disease.

The FDA said all three products are already being used in children even though they aren’t approved. Approved products include Risperdal, by a unit of Johnson & Johnson (JNJ), and Abilify by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co., Ltd, the agency said.

The FDA asked each company to look at which side effects were more commonly seen in children compared to adults who were studied in clinical trials.

Lilly said clinical studies of Zyprexa showed the product was associated with greater weight gain and changes in blood lipid parameters than seen in adults using the product.

The company is seeking FDA approval of Zyprexa as a second-treatment for children and adolescents, meaning that other products should be tried first. Zyprexa is Lilly’s top-selling drug with $4.7 billion annual sales in 2008.

AstraZeneca said side effects that occurred more frequently in children compared to adults on Seroquel included increases in blood pressure and increased appetite. The company also said incidences of certain movement side effects such as tremors were higher among patient taking Seroquel compared to patients in placebo groups, or patients not taking the drug. Seroquel is AstraZeneca’s second-best selling drug with $4.45 billion in sales in 2008.

Pfizer said children taking Geodon were more likely than adults to report feeling sleepy, or sedation. The company said the drug didn’t have a big impact on weight gain with 7% of people taking Geodon experiencing a 7% or greater gain in weight compared to 4% in the placebo group. The company also said the drug didn’t increase metabolic markers such as cholesterol.

Schizophrenia afflicts about 1% of Americans. According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don’t hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is also a cause of suicide and is typically diagnosed in a person’s late teens or 20s. Bipolar disorder also known as manic-depressive illness, is believed to affect about 1% to 3% of the population, and is characterized by unusual shifts in mood, energy and activity levels. There’s evidence that bipolar disorder in children is more severe than typically seen in adults.

- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; .(JavaScript must be enabled to view this email address)

(END) Dow Jones Newswires