Investigating the safety of Fampridine in patients with different stages of multiple sclerosis

Abstract

Background: Fampridine is the only drug that was approved by US Food and Drug Administration (FDA) for patients with multiple sclerosis to improve their movement and has exhibited a clinically significant improvement in gait function in subset of multiple sclerosis patients with Expanded Disability Status scale (ESDSS) from 4 to 7. Nevertheless, this drug has been reported to possess some adverse effects like seizure due to its pharmacological features. The aim of this study was to evaluate the incidence rate of post-medication side effects of Fampridine on multiple sclerosis patients. Method: This prospective cohort study includes MS patients aged between 18 years to 65 years, referred to neurology clinic of Kashani hospital from April 2022 to October 2022, all with administration of Fampridine (10mg tablet every 12 hours according to the product specifications) Safety in these patients is monitored through monthly side effects checklist questions during six months of screening. SPSS version 18 was used to analyze the data of this study. Result: A total of 254 patients with multiple sclerosis, including 127 RRMS, 101 SPMS, and 26 PPMS patients, were included in the study. The most observed adverse effects in SPMS and RRMS patients were dry mouth (13.9% vs. 15%) and insomnia (12.9% vs. 11%), respectively. UTI (11.5%), and stomachache (11.5%) were the most common side effects in PPMS patients. The most severe complication of the patients was back pain, and digestive complications were less severe. Also, insomnia, and UTI were the patients' most persistent side effects. Conclusion: The drug seems to be safe and well tolerated, as the side effects were mild and transient and they were similar with most of the previous studies focusing on this drug.