Background: Guillain-Barre Syndrome (GBS) is an autoimmune-mediated disorder that can be triggered by infections, autoimmune diseases, and certain medications. Still, a comprehensive list of drugs causing GBS has not been established. This study aims to comprehensively characterize patients who have developed GBS concerning various drugs and evaluate and compare their potential associations using the FDA Adverse Event Reporting System (FAERS). Methods: A Retrospective Pharmacovigilance study of the FAERS database was conducted to extract adverse reports related to GBS and its variants. Using open Vigil 2.1., all the drugs mentioned in the Adverse event reports were identified, and drugs with a reporting frequency> 20 underwent Disproportionality and Bayesian analyses. Furthermore, a literature search was conducted to identify existing evidence on drugs that showed significant associations.
Results: From 1989 to September 2022, 4883 adverse event reports related to GBS, and its variants were retrieved from 24,953,348 reports in the FAERS database. Excluding missing data, the patient's mean age was 53.80 ±18.54 years, and 50.65% were males. 92.4% of adverse event reports did not specify any GBS variant, while Miller-Fisher syndrome and Acute motor-sensory axonal neuropathy were the most reported variants. Most required hospitalization (64.33%), with 428 (9.3%) reported deaths. The Disproportionate and Bayesian analyses identified 60 drugs with significant signals, mainly Antineoplastic, Antimicrobial & Monoclonal antibodies. Drugs with ROR> 10 include Basiliximab, alemtuzumab, atezolizumab, ipilimumab, bortezomib, fludarabine, and stavudine. Basiliximab has the highest ROR (Reporting Odds Ratio) and PRR (Proportionality Reporting Ratio). The literature search verified that many case reports had previously linked these drugs to GBS.
Conclusion: Using FAERS, this study comprehensively characterizes patients who have developed GBS in relation to drugs and found a significant association between GBS and many Antineoplastic, Antimicrobial & Monoclonal antibodies, highlighting the utmost importance for healthcare providers to exercise caution when administering these medications.
Keywords
Drug Associated GBS; Drug Induced GBS; Faers; Drugs; Guillain Barre Syndrome; GBS