Side Effects of Seroquel, Zyprexa and Geodon Carry Risks for Children

FDA officials have expressed concerns to an independent panel of advisors that side effects of Seroquel, Zyprexa and Geodon may expose children to a risk of serious life-long disorders if the popular antipsychotics are approved for use among adolescence between ages 10 and 17.

While the drugs are already approved to treat schizophrenia and bipolar disorder in adults, the manufacturers are seeking approval to market the drugs to children as well.

An FDA panel of outside advisors is scheduled to meet Tuesday to review the risks and benefits of the drugs for children, and to decide whether to recommend for or against the expanded approval. While the FDA is not required to follow the panel’s recommendation, they usually do.

In documents released Friday, FDA officials indicated to the panel that the drugs do appear to work in children, but concerns were expressed about potential side effects the antipsychotics may cause if approval is expanded, such as weight gain, high blood sugar and diabetes.

“Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia,” the report states. “These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development.”

The potential problems with Seroquel, Zyprexa and Geodon pointed out by the reviewers are already associated with use by adults, and Eli Lilly & Co., the manufacturer of Zyprexa, and AstraZeneca, the manufacturer of Seroquel, have previously been criticized for failing to disclose the risk.

Eli Lilly paid over $2.5 billion to settle individual and government Zyprexa lawsuits over their allegedly fraudulent marketing of the drug for uses that were not approved by the FDA and for failing to adequately disclose the risk of diabetes and other side effects.

AstraZeneca is still dealing with more than 9,000 Seroquel lawsuits filed by users who allege that the drug maker failed to adequately warn users about the side effects of the drug, including weight gain, diabetes hyperglycemia and tardive dyskinesia, a rare movement disorder.