Drug-induced hypoglycemia: a disproportionality analysis of the FAERS database

ABSTRACT

Background

Hypoglycemia is an adverse event (AE) that cannot be ignored in clinical practice. This study aimed to identify the most common and top drugs associated with the risk of hypoglycemia based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.

Research design and methods

We used OpenVigil 2.1 pharmacovigilance analytics platform to query FAERS database and data from 2004 to 2023 were retrieved. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify hypoglycemia cases, and DrugBank database was used to determine drug generic names.

Results

A total of 11,155,106 AEs reports were identified, of which 28,443 (0.25%) were related to hypoglycemia. Metformin (6926 cases) was associated with most cases of hypoglycemia. According to the disproportionality analysis, the top five drugs with the highest ROR and PRR were penamecillin, nikethamide, sotagliflozin, norethandrolone, glimepiride/pioglitazone. Nineteen of the top 50 drugs did not have hypoglycemia indicated in the package insert.

Conclusions

By analyzing the FAERS database, we listed drugs with a strong hypoglycemic signal for which the label does not provide a reminder. Notably, the potential hypoglycemia risks are of great importance and should be closely monitored in medical practice.

KEYWORDS:

• Hypoglycemia
• FAERS
• disproportionality analysis
• pharmacovigilance

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Conceptualization, Jie Li and Zhitao Jiang; methodology, Yilei Wang, Xiang Yang and Haohao Zhu; writing – original draft preparation, Jie Li and Yilei Wang; writing – review and editing, Jie Li and Zhitao Jiang. All authors have read and agreed to the published version of the manuscript.

Additional information

Funding

This paper was not funded.