Background: Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous reporting archives of adverse drug reaction (ADRs). Research design and methods: We retrieved information from the US Food and Drug Administration Adverse Event Reporting System (FAERS) over a 13-year period. Reporting odds ratio (ROR) for MS was calculated for each single substance. Disproportionality signals were considered when at least 10 cases were retrieved with a lower limit of the 95% confidence interval (CI) >1. Results: After a customized data-mining process, 3,226 reports of MS were retrieved. ‘Antineoplastic and immunomodulating drugs’ (33% of total reports) were the most frequently reported, with 10 disproportionality signals, including etanercept (445 cases; ROR: 2.48; 95% Cl: 2.24–2.74), adalimumab (329; 2.05; 1.83–2.30), and infliximab (119; 2.25; 1.87–2.70). We also observed signals for drugs acting on hormone balance, bone density, and central nervous system. Conclusion: Our findings suggest that immunomodulatory drugs increase the risk of MS and point out that some other drug classes should be further investigated for this risk.

Antonazzo, I., Raschi, E., Forcesi, E., Riise, T., Bjornevik, K., Baldin, E., et al. (2018). Multiple sclerosis as an adverse drug reaction: clues from the FDA Adverse Event Reporting System. EXPERT OPINION ON DRUG SAFETY, 17(9), 869-874 [10.1080/14740338.2018.1506763].

Multiple sclerosis as an adverse drug reaction: clues from the FDA Adverse Event Reporting System

Antonazzo I. C.;
2018

Abstract

Background: Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous reporting archives of adverse drug reaction (ADRs). Research design and methods: We retrieved information from the US Food and Drug Administration Adverse Event Reporting System (FAERS) over a 13-year period. Reporting odds ratio (ROR) for MS was calculated for each single substance. Disproportionality signals were considered when at least 10 cases were retrieved with a lower limit of the 95% confidence interval (CI) >1. Results: After a customized data-mining process, 3,226 reports of MS were retrieved. ‘Antineoplastic and immunomodulating drugs’ (33% of total reports) were the most frequently reported, with 10 disproportionality signals, including etanercept (445 cases; ROR: 2.48; 95% Cl: 2.24–2.74), adalimumab (329; 2.05; 1.83–2.30), and infliximab (119; 2.25; 1.87–2.70). We also observed signals for drugs acting on hormone balance, bone density, and central nervous system. Conclusion: Our findings suggest that immunomodulatory drugs increase the risk of MS and point out that some other drug classes should be further investigated for this risk.
Articolo in rivista - Articolo scientifico
Drugs exposure; hormones; multiple sclerosis; reporting odds ratio; spontaneous reporting system (FAERS); tumor necrosis factor inhibitor;
English
869
874
6
Antonazzo, I., Raschi, E., Forcesi, E., Riise, T., Bjornevik, K., Baldin, E., et al. (2018). Multiple sclerosis as an adverse drug reaction: clues from the FDA Adverse Event Reporting System. EXPERT OPINION ON DRUG SAFETY, 17(9), 869-874 [10.1080/14740338.2018.1506763].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/400965
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