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

Objective: To investigate and analyze the post-marketing adverse event (AE) data of multiple sclerosis (MS) therapeutic drug dalfampridine using US Food Drug Administration Adverse Event Reporting System (FAERS) for its clinical safety application. Methods: Use OpenVigil2.1 platform to obtain AE from FAERS February 2010 September 2022. Match “adverse reaction” with preferred term (PT) system organ class (SOC) according Medical Dictionary Regulatory Activities (MedDRA), then merge same PT delete non-AE PT. Positive signals were identified by reporting odds ratio (ROR), proportional (PRR), Bayesian confidence propagation neural network (BCPNN) methods. When met criteria those three methods, they as positive signals. Results: A total 44,092 dalfampridine-related reports obtained, 335 identified, including 11,889 reports. AEs more common in females 45–65 age group, which is consistent epidemiological characteristics MS. The involved 21 SOCs, investigations, infections infestations, eye disorders, etc. Among top 20 PTs signal strength, 10 associated abnormal lymphocyte percentage count, 5 urine tests, some not described instruction, such spinal cord injury cauda equina, haemoglobin present, urinary sediment so on. most frequently reported tract infection, dizziness, condition aggravated. In addition, 23 death outcomes an incidence less than 0.1%. Conclusion: Data mining was conducted dalfampridine, new found. This study provides a reference safe use treatment