The New York Times
Monday, January 06, 2003
U.S. Approves Prozac for Treating Children
By BLOOMBERG NEWS
WASHINGTON, Jan. 3 (Bloomberg News) — Prozac, the antidressant made by Eli Lilly, was approved for treating children and adolescents with depression, federal regulators said today.
The Food and Drug Administration cleared Prozac for use in treating patients 7 to 17 years of age, the agency said after reviewing Lilly's research on the drug's safety. Lilly does not plan to promote the depression pill for children, the company said.
For years, doctors have prescribed Prozac and similar drugs for children even though these medications were approved only for adults. Federal officials wanted to review safety issues for the drug, once the world's top-selling depression treatment with annual sales of more than $2 billion.
"Depression is a serious illness in all age groups, but unlike the adult population, there has been a lack of data available regarding the effects of medications in the treatment of child and adolescent depression," a Lilly spokesman, Blair Austin, said.