On Thursday, September 20, 2018, the Pediatric Advisory Committee (PEDAC) discussed pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).
The committee heard pediatric-focused safety reviews for Intuniv (guanfacine) and Lexapro (escitalopram). For each of these drugs, the committee voted in favor, by a vote of 11-Yes and 1No, of the monitoring proposed by the FDA’s Division of Pharmacovigilance (DPV). For Intuniv, the DPV proposed to continue monitoring for adverse events (AEs), including suicidal ideation and behavior, pancreatitis, and medication error involving name confusion. For Lexapro, the DPV proposed to continue routine safety monitoring