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

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Drug Safety

Background:

• Hypomagnesemia is a common yet often underdiagnosed condition.
• The association between adverse drug reactions and hypomagnesemia is not always evident.
• Some drug labels fail to disclose the risk of hypomagnesemia, posing a significant danger.

Purpose of the Study:

• To identify drugs associated with hypomagnesemia using a large adverse event database.
• To assess the strength of the signal for specific drugs causing hypomagnesemia.
• To evaluate whether hypomagnesemia risk is adequately labeled for identified signal drugs.

Main Methods:

• Cross-sectional study utilizing FDA Adverse Event Reporting System (FAERS) data from Q1 2004 to Q4 2023.
• Identification of hypomagnesemia cases using the Medical Dictionary for Regulatory Activities (MedDRA).
• Descriptive and disproportionality analyses for signal detection of causative drugs.

Main Results:

• 11,228 individual safety reports (ISRs) for hypomagnesemia were identified from over 17 million adverse event reports.
• Omeprazole (20.75%) and pantoprazole were most frequently reported drugs.
• Necitumumab showed the strongest signal for causing hypomagnesemia, followed by capreomycin and panitumumab.
• 31 of the top 50 drugs identified lacked hypomagnesemia warnings on their labels.

Conclusions:

• Several drugs, including proton pump inhibitors and specific cancer therapies, are associated with hypomagnesemia.
• A significant number of drugs linked to hypomagnesemia do not carry adequate warnings.
• Urgent attention is needed for drug-induced hypomagnesemia, especially with combination therapies, and further research is recommended.