http://www.nytimes.com/2003/07/27/science/27HORM.html?ex=1064635200&en=2ea995886c50ed77&ei=5070

A Hormone to Help Youths Grow Is Approved by F.D.A.

By THE ASSOCIATED PRESS

ASHINGTON, July 26 (AP) — Children who are healthy but abnormally short will be able to have injections of growth hormone in hope of gaining one to three more inches of height, the Food and Drug Administration said Friday, deciding an emotionally charged issue.

The drug, Humatrope, is not for normal children yearning for a few extra inches, the agency cautioned. It is for the shortest 1.2 percent.

The drug's maker, Eli Lilly & Company, counts about 400,000 such children ages 7 to 15, but predicts that only 10 percent will receive growth hormone because of eligibility restrictions and because six shots a week are required for years.

"This is not cosmetic use," said Dr. David Orloff, the agency's chief of endocrinology.

Growth hormone has been used for 16 years to treat children who are extremely short because their bodies do not produce the substance or because of diseases. Some 200,000 children worldwide have taken it.

Lilly sought federal approval to market its brand of growth hormone for children who do not have those medical conditions but are still abnormally short: boys predicted to be shorter than 5-foot-3 as adults, and girls shorter than 4-foot-11.

Lilly's studies of about 300 children with no known causes of abnormal shortness found injections added an average of 1.5 inches to 2.8 inches of height by adulthood.

Lilly pledged tight restrictions on Humatrope's availability. It will be prescribed only by certain specialists and shipped by special drug stores to patients who undergo tests.

Copyright 2003 The New York Times Company