TY - JOUR
T1 - Hypoglycemia Associated with Antibiotics Alone and in Combination with Sulfonylureas and Meglitinides
T2 - An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)
AU - Kennedy, Kaitlin E.
AU - Teng, Chengwen
AU - Patek, Taylor M.
AU - Frei, Christopher R.
N1 - Funding Information:
No funding was sought for this research study. Dr. Frei was supported, in part, by a National Institutes of Health (NIH) Clinical and Translational Science Award (National Center for Advancing Translational Sciences, UL1 TR001120, UL1 TR002645, and TL1 TR002647) while the study was being conducted. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Funding Information:
The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs, the National Institutes of Health, or the authors? affiliated institutions.
Publisher Copyright:
© 2019, Springer Nature Switzerland AG.
PY - 2020/4/1
Y1 - 2020/4/1
N2 - Introduction: Fluoroquinolones, clarithromycin, linezolid, tigecycline, cefditoren, doxycycline, and trimethoprim–sulfamethoxazole are known to be associated with hypoglycemia, but few studies have considered concomitant glucose-lowering medications. Objective: The objective of this study was to evaluate the association between hypoglycemia and antibiotics using the US Food and Drug Administration Adverse Event Reporting System (FAERS), while accounting for concomitant glucose-lowering medications including sulfonylureas and meglitinides. Methods: FAERS reports from 1 January 2004 to 31 December 2017 were included in the study. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) 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 > 1.0. Results: A total of 2,334,959 reports (including 18,466 hypoglycemia reports) were considered, after inclusion criteria were applied. 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), and linezolid 1.54 (1.07–2.20). After adjusting for concomitant sulfonylureas and meglitinides, the following antibiotics were still significantly associated with hypoglycemia: cefditoren 14.25 (9.08–22.39), tigecycline 3.34 (1.96–5.68), ertapenem 1.93 (1.03–3.60), and clarithromycin 1.56 (1.15–2.11). Conclusion: In many patients, antibiotics, including fluoroquinolones, are associated with hypoglycemia when they are also taking sulfonylureas or meglitinides. Cefditoren, tigecycline, ertapenem, and clarithromycin are associated with hypoglycemia even if not taken with sulfonylureas or meglitinides. The association between ertapenem and hypoglycemia has not been previously reported.
AB - Introduction: Fluoroquinolones, clarithromycin, linezolid, tigecycline, cefditoren, doxycycline, and trimethoprim–sulfamethoxazole are known to be associated with hypoglycemia, but few studies have considered concomitant glucose-lowering medications. Objective: The objective of this study was to evaluate the association between hypoglycemia and antibiotics using the US Food and Drug Administration Adverse Event Reporting System (FAERS), while accounting for concomitant glucose-lowering medications including sulfonylureas and meglitinides. Methods: FAERS reports from 1 January 2004 to 31 December 2017 were included in the study. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) 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 > 1.0. Results: A total of 2,334,959 reports (including 18,466 hypoglycemia reports) were considered, after inclusion criteria were applied. 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), and linezolid 1.54 (1.07–2.20). After adjusting for concomitant sulfonylureas and meglitinides, the following antibiotics were still significantly associated with hypoglycemia: cefditoren 14.25 (9.08–22.39), tigecycline 3.34 (1.96–5.68), ertapenem 1.93 (1.03–3.60), and clarithromycin 1.56 (1.15–2.11). Conclusion: In many patients, antibiotics, including fluoroquinolones, are associated with hypoglycemia when they are also taking sulfonylureas or meglitinides. Cefditoren, tigecycline, ertapenem, and clarithromycin are associated with hypoglycemia even if not taken with sulfonylureas or meglitinides. The association between ertapenem and hypoglycemia has not been previously reported.
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U2 - 10.1007/s40264-019-00901-7
DO - 10.1007/s40264-019-00901-7
M3 - Article
C2 - 31863282
AN - SCOPUS:85077141312
VL - 43
SP - 363
EP - 369
JO - Drug Safety
JF - Drug Safety
SN - 0114-5916
IS - 4
ER -