Ciprofloxacin and Risk of Hypoglycemia in Non-diabetic Patients

Abiel Berhe; Mulugeta Russom; Fithawit Bahran; Goitom Hagos

Disclosures

J Med Case Reports. 2019;13(142) 

In This Article

Methods

On August 15, 2018, a search was made in the WHO global suspected adverse drug reactions (ADR) database (VigiBase®), which is developed and maintained by the Uppsala Monitoring Center (UMC), Sweden. As of September 13, 2018, the database contained over 18 million individual case safety reports (ICSRs) submitted from 130-plus countries since 1968.[16]

The search criteria used were "ciprofloxacin" as the drug substance and "hypoglycemia" (high-level group term) as the reaction MedDRA (Medical Dictionary for Regulatory Activities) term. Reaction outcomes, seriousness, information component (IC), de-challenge and rechallenge, and other relevant information were retrieved using VigiLyze, UMC's tool developed to analyze data from VigiBase. The IC value is a measure of disproportionality of drug-ADR in VigiBase as discussed by Bate et al. and Norén et al..[17,18] A positive IC value is a traditional threshold that indicates a drug-ADR pair is reported more often than expected based on all reports in VigiBase, thus showing a statistical signal. The results generated were then exported to an Excel 2016 spreadsheet (Microsoft, Redmond, WA, USA) for descriptive analysis. Potential duplicate cases were eliminated using VigiMatch™, a tool developed by the UMC.

Patients on antidiabetic medications and/or known to have a history of diabetes were excluded from the study to rule out the effect of hypoglycemic agents. Moreover, cases with completeness scores less than 50% were also excluded to improve the strength of information.

Hill's criteria were used to assess causation, whereas "labeled-ness" or expectedness of the adverse event was checked by referring to the summary of product characteristics of ciprofloxacin and reviewing medical literature.[19]

Comments

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