The U. S. Food and Drug Administration medical reviewers said that Friday the agency should conduct an additional review of antipsychotic drugs to check the impact of weight gain in children, which is a common side-effect of the drugs.
Labels for the drugs, which include AstraZeneca PLC’s Seroquel and Eli Lilly & Co.’s Zyprexa already, warn of increases in weight along with other side-effects. Nevertheless, the FDA clarified that those warnings were not specific to the younger patients.
The recommendation for additional study of the impact of weight gain in children came as the agency officially approved the use of Zyprexa on Friday. It is meant for use in children of ages 13 to
17 and Seroquel for use in children as young as 10 to treat bipolar disorder and schizophrenia.
Previously the drugs were 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 since the increased potential for weight gain and cholesterol in adolescents compared to adults.
Top News United States has contributed to the report.