Drug-induced Guillain-Barré Syndrome: a disproportionality analysis based on the US FDA adverse event reporting system.

Abstract

Background: Guillain-Barré Syndrome (GBS) is a rare but severe neurological disorder often precipitated by infections, vaccines, and potentially by certain medications. Drug-induced GBS, though less commonly reported, presents significant diagnostic and therapeutic challenges. This study investigates the correlation between various medications and the onset of GBS.

Research design and methods: We conducted a retrospective pharmacovigilance analysis using data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q1 2024. The analysis focused on identifying drugs frequently associated with GBS and examining the time-to-onset and severity of these events.

Results: From over 17 million adverse events, 1,869 cases were identified as drug-induced GBS. Monoclonal antibodies and immunomodulators were the most frequently implicated drug classes. The median time-to-onset for GBS was within the first 30 days following drug exposure. Approximately 51.8% of the cases resulted in severe outcomes, such as hospitalization or disability. Drugs such as brentuximab vedotin and efalizumab showed strong associations with GBS occurrences.

Conclusions: This study highlights the importance of monitoring for GBS symptoms following the administration of certain medications, particularly those that affect immune function, and underscores the need for healthcare providers to be aware of the potential neurological risks associated with these medications.