Zyprexa Side Effects for Children Lead to Revised FDA Warnings

The FDA has required the drug maker Eli Lilly to update the warning label for their popular antipsychotic Zyprexa about potential weight-gain side effects among children.

According to an FDA statement posted on Friday for neuropsychiatric healthcare professionals, Zyprexa side effects can lead to increased potential for weight gain and hyperlipidemia in children ages 13 through 17. The warning also suggests that prescribing doctors may want to look at other medications first, due to Zyprexa health risks for adolescents, which can include high cholesterol and diabetes.

“When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia,” the warning reads. “Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.”

The warnings come after an October study published in the Journal of the American Medical Association linked use of Zyprexa to dramatic weight gain among children. The study found that among children between 4 and 19, side effects of Zyprexa resulted in an average weight gain of 18.7 pounds after only 11 weeks. Researchers also found similar problems with other antipsychotics in the same class, with side effects of Seroquel causing children to gain an average of 13.5 pounds, Risperdal causing an average increase of 11.7 pounds and Abilify causing an average weight gain of 9.7 pounds.

In recent years, Eli Lilly has faced a number of lawsuits over Zyprexa in the United States and Canada involving allegations that the drug maker failed to adequately warn about the risk of diabetes and other problems caused by the risk of weight-gain associated with the drug. Lilly has also been accused of fraudulent marketing of the drug for uses that they had not established were safe or effective.