Annals of the American Thoracic Society
Mental health safety profile of CFTR modulators in pediatrics and adults: insights from the French pharmacovigilance database and from VigiBase
Abstract Rationale CFTR modulators (CFTRms) have transformed cystic fibrosis care, yet concern exists regarding their mental health safety profile. Objective To provide further information, we conducted an analysis of CFTRm-related mental health disorders using two spontaneous pharmacovigilance reporting databases in real-world settings. Methods We analyzed reports from the French Pharmacovigilance Database (FPD) and VigiBase, the WHO global individual case safety reports database. Reports recorded between 2012 and …