Data mining and analysis of adverse drug reaction signals of fampridine sustained-release tablets based on FAERS database

doi:10.19803/j.1672-8629.20220212

Abstract

Abstract: Objective To provide reference for clinical safe drug use via data mining of adverse drug events /adverse drug reaction (ADE/ADR) caused by fampridine sustained-release tablets. Methods Based on the FDA Adverse Event Reporting System (FAERS), the ADR/ADE reports of fampridine sustained-release tablets submitted between January 2013 and June 2021 were mined by using the reporting odds ratio (ROR) method and information component (IC) method. Statistical analysis was conducted according to the preferred terms (PT) and system organ classification (SOC) in the International Dictionary of Medical Terms (MedDRA). Results A total of 141 768 ADR/ADE were reported with fampridine sustained-release tablets as the primary suspected drug, involving 47 486 patients, most of whom were females (72.39%) and aged 41 to 70 (82.83%). The United States was the leading reporting country (90.98%). There were 7 873 serious ADR/ADE (16.58%), which mostly resulted in hospitalizations or prolonged hospitalizations (12.24%). A total of 174 positive signals were detected after screening, 126 of which were not recorded in the instructions. There were 36 PT positive signals in the top 50 cases of ADR/ADE reported, and 30 PTs not recorded in the instructions. The top 50 PTs in terms of signal intensity that involved SOC included various examinations (19 cases), neurological diseases (11 cases), systemic diseases and various reactions of sites of administration (5 cases). There were 13 system and organs involved in effective signals, involving general disorders and administration site conditions (28.53%). nervous system disorders (26.03%) and psychiatric disorders (8.79%). Conclusion The real-world data analysis of ADR/ADE caused by newly-marketed fampridine sustained-release tablets suggests that clinicians should strictly follow the instructions and care about the patients' history of epilepsy and renal function. Furthermore, some new and stronger signals have been detected, such as abnormal T cells, CD4 lymphocytes and B cells. Therefore, clinicians should closely monitor the results of examinations of patients and stay alert to risks unmentioned in instructions, such as neurological diseases.

Key words: aminopyridine sustained-release tablet, American FAERS database, adverse drug event/ reaction, data mining

CLC Number:

R994.11

ZHAO Wenhua, SHU He, NI Chenming, GUO Jinmin. Data mining and analysis of adverse drug reaction signals of fampridine sustained-release tablets based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 684-690.

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