Detection and warning of drug-induced hypomagnesemia: a pharmacovigilance study of the FDA Adverse Event Reporting System.

Abstract

Hypomagnesemia, a common condition, frequently goes unnoticed due to varying symptom severity. In the hospital setting, the link between adverse drug reactions and hypomagnesemia is not always clear, and some drug labels omit this risk, compounding the potential danger. We conducted a cross-sectional study by mining data from the FDA Adverse Event Reporting System (FAERS) covering Q1 2004 to Q4 2023. Using the Medical Dictionary for Regulatory Activities, we identified cases of hypomagnesemia, determined the signal drugs causing hypomagnesemia based on the drug name, and employed descriptive and disproportionality analysis methods for signal detection. From 17,381,220 adverse event reports, 11,228 individual safety reports (ISRs) involving hypomagnesemia were identified. Omeprazole led with 1,556 reports (20.75%), followed by pantoprazole, panitumumab, cetuximab, and esomeprazole. Disproportionality analysis revealed necitumumab as the drug with the strongest signal, followed by capreomycin, panitumumab, pantoprazole, and omeprazole. Among the top 50 drugs from the disproportionality analysis, 31 signal drugs had labels that did not mention the risk of hypomagnesemia. We issue warnings regarding drugs associated with specific combination therapies that cause adverse reactions leading to hypomagnesemia. Furthermore, to delve deeper into the relationship between drugs and hypomagnesemia, reliance on more credible research in this field is required.