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

Frontiers in Pharmacology

Pharmacology

Yi Huang¹  Wei Wu²  Jing Lei²  Yongtao Tong³  Hong Zhang³  Rui Xiong⁴  Sicen Pan⁴  Xiaodan Lai⁴ 

[1] Biomedical Analysis Center, Army Medical University, Chongqing, China;Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China;Department of Pharmacy, The 956th Hospital of Chinese People’s Liberation Army, Nyingchi, Tibet, China;Department of Pharmacy, The 958th Hospital of Chinese People’s Liberation Army, Chongqing, China;

关键词: FAERS;    dalfampridine;    multiple sclerosis;    adverse event;    pharmacovigilance;   

DOI  :  10.3389/fphar.2023.1226086

 received in 2023-05-24, accepted in 2023-09-04,  发布年份 2023

来源: Frontiers

【 摘 要 】

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 those three methods, they were identified as positive signals.Results: A total of 44,092 dalfampridine-related AE reports were obtained, and 335 AE signals were identified, including 11,889 AE reports. AEs were more common in females and in the 45–65 age group, which is consistent with the epidemiological characteristics of MS. The 335 AE signals involved 21 SOCs, including investigations, infections and infestations, eye disorders, etc. Among the top 20 PTs in signal strength, 10 were associated with abnormal lymphocyte percentage and count, and 5 were associated with abnormal urine tests, some of which were not described in the instruction, such as spinal cord injury cauda equina, haemoglobin urine present, urinary sediment abnormal and so on. The most frequently reported AE signals were urinary tract infection, dizziness, condition aggravated. In addition, 23 AE signals with death outcomes were identified, with an incidence of less than 0.1%.Conclusion: Data mining of FAERS was conducted to analyze the AEs of dalfampridine, and new AE signals were found. This study provides a reference for the safe use of dalfampridine in the treatment of MS.

【 授权许可】

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Copyright © 2023 Xiong, Lei, Pan, Zhang, Tong, Wu, Huang and Lai.