Post-marketing safety surveillance of dalfampridine for multiple sclerosis using FDA adverse event reporting system.

ABSTRACT: Objective: To investigate and analyze the post-marketing adverse event (AE) data of multiple sclerosis (MS) therapeutic drug dalfampridine using the US Food and Drug Administration Adverse Event Reporting System (FAERS) for its clinical safety application. Methods: Use OpenVigil2.1 platform to obtain AE data of dalfampridine from FAERS from February 2010 to September 2022. Match "adverse drug reaction" with preferred term (PT) and system organ class (SOC) according to the Medical Dictionary for Regulatory Activities (MedDRA), then merge the same PT and delete non-AE PT. Positive signals were identified by the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) methods. When AE signals met the criteria of t

SUBMITTER: Xiong R 

PROVIDER: S-EPMC10538962 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature