Editor’s note: This is the second of 12 articles from the Food and Drug Administration (FDA) highlighting some of the 500 products that have received new pediatric labeling information since 1998. This summary includes the cardiovascular products that recently have been studied in pediatrics and some of the issues that occur when trying to define appropriate pediatric dosing and endpoints.
The Division of Cardiovascular and Renal Products, one of 16 review divisions within the FDA Center for Drug Evaluation and Research, is responsible for helping sponsors develop studies in their therapeutic areas in children.
Over the past 12 years, 19 cardiovascular products have been studied in the pediatric population, including 14 antihypertensives and one each for heart failure, arrhythmia suppression, bronchopulmonary dysplasia (BPD), pulmonary arterial hypertension (PAH) and thrombosis prevention.
Efficacy in the pediatric population was demonstrated in 11 of the 19 products. Of the remaining eight products, three antihypertensives...