FDA is concerned that use of finasteride by pediatric patients may pose long-term safety risks.

Finasteride inhibits Type II 5(alpha)-reductase, which metabolizes testosterone to the potent androgen 5(alpha)-dihydrotestosterone. FDA is concerned that use of finasteride by pediatric patients may pose long-term safety risks regarding growth, development and sexual function.

—FDA response to Merck & Co.’s citizen petition requesting that finasteride be added to the List of Approved Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population: May 2000