Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System.
Adverse Drug Reaction Reporting Systems
Amyotrophic Lateral Sclerosis
/ chemically induced
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
/ adverse effects
Immunologic Factors
Omalizumab
Pharmaceutical Preparations
Tumor Necrosis Factor-alpha
United States
/ epidemiology
United States Food and Drug Administration
Ustekinumab
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
06 2022
06 2022
Historique:
accepted:
26
04
2022
pubmed:
25
5
2022
medline:
15
6
2022
entrez:
24
5
2022
Statut:
ppublish
Résumé
Amyotrophic lateral sclerosis is a fatal progressive disease with a still unclear multi-factorial etiology. This study focused on the potential relationship between drug exposure and the development of amyotrophic lateral sclerosis by performing a detailed analysis of events reported in the FDA Adverse Event Reporting System database. The FDA Adverse Event Reporting System quarterly data (January 2004-June 2020) were downloaded and deduplicated. The reporting odds ratios and their 95% confidence intervals were calculated as a disproportionality measure. The robustness of the disproportion was assessed accounting for major confounders (i.e., using a broader query, restricting to suspect drugs, and excluding reports with amyotrophic lateral sclerosis as an indication). Disproportionality signals were prioritized based on their consistency across analyses (reporting odds ratio stability). We retained 1188 amyotrophic lateral sclerosis cases. Sixty-two drugs showed significant disproportionality for amyotrophic lateral sclerosis onset in at least one analysis, and 31 had consistent reporting odds ratio stability, including tumor necrosis factor-alpha inhibitors and statins. Disproportionality signals from ustekinumab, an immunomodulator against interleukins 12-23 used in autoimmune diseases, and the anti-IgE omalizumab were consistent among analyses and unexpected. For each drug emerging as possibly associated with amyotrophic lateral sclerosis onset, biological plausibility, underlying disease, and reverse causality could be argued. Our findings strengthened the plausibility of a precipitating role of drugs primarily through immunomodulation (e.g., tumor necrosis factor-alpha, ustekinumab, and omalizumab), but also by impacting metabolism and the musculoskeletal integrity (e.g., statins and bisphosphonates). Complement and NF-kB dysregulation could represent interesting topics for planning translational mechanistic studies on amyotrophic lateral sclerosis as an adverse drug effect.
Identifiants
pubmed: 35610460
doi: 10.1007/s40264-022-01184-1
pii: 10.1007/s40264-022-01184-1
doi:
Substances chimiques
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Immunologic Factors
0
Pharmaceutical Preparations
0
Tumor Necrosis Factor-alpha
0
Omalizumab
2P471X1Z11
Ustekinumab
FU77B4U5Z0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
663-673Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
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