TY - CHAP M1 - Book, Section TI - Chapter 9. Challenges of Clinical Trials in Pediatrics A1 - Turner, Kevin N. A1 - Smith, P. Brian A2 - Lopes, Renato D. A2 - Harrington, Robert A. PY - 2013 T2 - Understanding Clinical Research AB - Cisapride was a medication approved by the US Food and Drug Administration (FDA) in 1993 for nighttime heartburn in adults. It was never shown to be effective or safe in children under the age of 16 and therefore had no FDA approval for use in this population (1,2). However, cisapride quickly found a market treating a common neonatal problem, gastroesophageal reflux (GER). There was a flavored syrup formulation that was labeled for use in geriatrics, but 90% of its sales were for use in pediatric patients (3). Hospitalized preterm infants also receive medications for symptoms thought to be associated with GER, including apnea, bradycardia, coughing, choking, and cyanosis (4,5). By 1998, more than 19% of infants in neonatal intensive care units (NICUs) in the United States were receiving cisapride (4). SN - PB - The McGraw-Hill Companies CY - New York, NY Y2 - 2024/10/15 UR - accessbiomedicalscience.mhmedical.com/content.aspx?aid=57836104 ER -