FDA GUIDANCE COVERS STUDIES OF CORTICOSTEROIDS IN CHILDREN

The FDA issued a final guidance giving recommendations on how to design, conduct and evaluate clinical studies looking at the effects of corticosteroids on growth in children.

In July 1998, a joint advisory committee reviewed findings that suggested inhaled and intranasal corticosteroids, used to treat allergic rhinitis and asthma, could decrease linear growth in children. The studies submitted to the FDA suggested that children exposed to corticosteroids had a reduced growth velocity of approximately 1 centimeter per year.

The committees recommended placing a precautionary statement on the products' labeling, but did not have sufficient data to determine the drugs' real effect on growth because the reviewed studies varied too much in design, the FDA said.

The final guidance, "Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children," will help researchers design studies the agency can use to assess the drugs, the FDA said. The recommendations will reduce the variability and potential bias of estimated differences in growth velocity between treatment groups, according to the agency.

The goal of a growth study should be to estimate the difference in prepubescent growth velocities between patients treated with an active corticosteroid and patients in the control group, the FDA said. The guidance addresses the appropriate patient populations to study, inclusion and exclusion criteria, adherence assessments and recommended sample size calculations.

The guidance can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0432-gdl0002.pdf.