FDA Refuses New Warnings on Estrogen for Tall Girls

Despite the health complications caused by hormones, the FDA will continue allowing physicians to prescribe estrogens to suppress growth in tall girls. PCRM had petitioned the FDA in February 2002, asking the agency to mandate new product labeling, making clear that estrogen is not approved for this purpose and that serious side effects have been associated with long-term use of the drug. Although estrogens have been used for this unapproved “off-label” purpose since the 1950s, no studies have ever monitored adverse effects in patients for more than ten years post-treatment. Many physicians reject the practice, but it remains legal.

A 2002 study of 1,419 children, published in the British Journal of Clinical Pharmacology, found that off-label drug use was associated with increased risk of adverse drug reactions in pediatric outpatients. Previous studies found that one-third to one-half of adverse drug reactions occurring in pediatric hospitals involved off-label drug use.