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

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.

• Authors: Ippazio Cosimo Antonazzo, Emanuel Raschi, Emanuele Forcesi, Trond Riise, Kjetil Bjornevik, Elisa Baldin, Fabrizio De Ponti, Elisabetta Poluzzi
• Journal: Expert opinion on drug safety (Expert Opin Drug Saf) Vol. 17 Issue 9 Pg. 869-874 (Sep 2018) ISSN: 1744-764X [Electronic] England
• PMID: 30058390 (Publication Type: Journal Article)

Chemical References

• Antineoplastic Agents
• Immunologic Factors

Topics

• Adolescent
• Adult
• Adverse Drug Reaction Reporting Systems (statistics & numerical data)
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Humans
• Immunologic Factors (administration & dosage, adverse effects)
• Infant
• Male
• Middle Aged
• Multiple Sclerosis (chemically induced, epidemiology)
• United States
• United States Food and Drug Administration
• Young Adult