2296. Hypoglycemia Risk with Antibiotics: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)

Abstract

Abstract Background In July of 2018, the FDA published a drug safety warning for the potential risk of developing hypoglycemia with fluoroquinolones. Some studies have evaluated the potential risk of developing hypoglycemia with linezolid and tigecycline. A few case reports have also been published that report hypoglycemia from cefditoren, doxycycline, and trimethoprim-sulfamethoxazole use. Since data comparing various antibiotics and the risk of developing hypoglycemia is limited, the objective of this study was to evaluate the association between hypoglycemia and antibiotics using the FDA Adverse Event Reporting Systems (FAERS). Methods FAERS reports from January 1, 2004 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of hypoglycemia. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and hypoglycemia were calculated. An association was considered to be statistically significant when the lower limit of the 95% CI was greater than 1.0. Results A total of 2,334,959 reports (including 18,466 hypoglycemia reports) were considered, after inclusion criteria were applied. Cefditoren had the greatest proportion of hypoglycemia reports, representing 10% of all cefditoren reports. Statistically significant hypoglycemia RORs (95% CI) for antibiotics were: cefditoren 14.03 (8.93–22.03), tigecycline 3.32 (1.95–5.65), clarithromycin 2.41 (1.89–3.08), ertapenem 2.07 (1.14–3.75), moxifloxacin 2.06 (1.59–2.65), levofloxacin 1.66 (1.37–2.01), linezolid 1.54 (1.07–2.20). Conclusion Cefditoren, tigecycline, clarithromycin, ertapenem, moxifloxacin, levofloxacin, and linezolid were all significantly associated with hypoglycemia. The ertapenem association had not been reported in prior literature. Levofloxacin and moxifloxacin were the only fluoroquinolones significantly associated with hypoglycemia, even though the FDA drug safety warning was issued for all fluoroquinolones. Doxycycline and trimethoprim-sulfamethoxazole were not significantly associated with hypoglycemia, even though case reports have reported hypoglycemia with doxycycline and trimethoprim-sulfamethoxazole. Disclosures All authors: No reported disclosures.