Abstract
BackgroundFluoroquinolones have been associated with hypoglycemia in patients taking diabetic medications, most commonly due to drug-drug interactions and other associated risk factors. Except for four published case reports, there are no studies that have found positive associations between ciprofloxacin and hypoglycemia. In all but one of the cases, ciprofloxacin was taken with other hypoglycemic drugs. Recently, the Eritrean National Pharmacovigilance Centre received a serious case of hypoglycemia with recurrent episodes in a young and healthy patient without diabetes following use of oral ciprofloxacin. The aim of the present study is therefore to assess the causal relationship between ciprofloxacin and hypoglycemia in patients without diabetes using the World Health Organization-Uppsala Monitoring Centre global adverse drug reaction database (VigiBase®).MethodsA search was made on the World Health Organization global adverse drug reaction database (August 15, 2018) using “ciprofloxacin” as the drug substance and “hypoglycemia” as the reaction term. Cases that used hypoglycemic drugs (patients with diabetes) concurrently with ciprofloxacin and those with a completeness score below 50% were excluded to control for confounders and to improve the strength of the data. Hill criteria were used to assess causation.ResultsA total of 35 cases of hypoglycemia reported since 1989 from 17 countries in patients without diabetes associated with ciprofloxacin use with a median time to onset of 4 days were retrieved. The cases have a median age of 64 years (interquartile range, 50–85) with a similar male–to-female ratio. Ciprofloxacin was the only suspect and the sole drug administered in 48.5% of the cases. In ten cases, hypoglycemia abated following withdrawal of ciprofloxacin, and reaction recurred in one case on the subsequent rechallenge. Hypoglycemia was marked as “serious” in 20 cases, and the outcome was fatal in two cases.ConclusionsThis assessment found a suggestive causal link between use of ciprofloxacin and hypoglycemia in patients without diabetes.
Highlights
Fluoroquinolones have been associated with hypoglycemia in patients taking diabetic medications, most commonly due to drug-drug interactions and other associated risk factors
Results the complete description of the single case of hypoglycemia reported from Eritrea and the characteristics of similar reports retrieved from VigiBase are presented
Case presentation A 28-year-old nonalcoholic and previously healthy businessman from the Tigrigna ethnic group, weighing 56 kg and with no previous exposure to ciprofloxacin, presented with hypoglycemia following intake of ciprofloxacin 500 mg oral twice daily for the treatment of urinary tract infection. He presented with chief complaints of blurred vision, headache, excessive sweating, and extreme hunger 4 days after the commencement of ciprofloxacin (December 4, 2017), which were relieved by consuming food
Summary
Fluoroquinolones have been associated with hypoglycemia in patients taking diabetic medications, most commonly due to drug-drug interactions and other associated risk factors. Except for four published case reports, there are no studies that have found positive associations between ciprofloxacin and hypoglycemia. The Eritrean National Pharmacovigilance Centre received a serious case of hypoglycemia with recurrent episodes in a young and healthy patient without diabetes following use of oral ciprofloxacin. Fluoroquinolones, the commonly used antibacterials, have been associated with dysglycemia (hypoglycemia and/or hyperglycemia) mainly in patients with diabetes taking either oral hypoglycemic agents or insulin [1]. Most of the patients who developed hypoglycemia following fluoroquinolone use had risk factors such as old age, diabetes, renal insufficiency, and concomitant use of hypoglycemic drugs, especially sulfonylureas [2,3,4]. On July 10, 2018, the U.S Food and Drug Administration (FDA), in its review of postmarket
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