A Review of the Food and Drug Administration Adverse Event Reporting System for Tramadol-Related Hypoglycemia

Authors

Katherine Juba, St. John Fisher UniversityFollow
Robbert Van Manen, Oracle Health Sciences Global Business Unit
Shawn E. Fellows, St. John Fisher UniversityFollow

Document Type

Article

Publication Date

10-25-2019

Keywords

fsc2020

Abstract

Background: Hypoglycemia is a rare adverse effect of tramadol that is described in the medical literature and package insert. Objective: The purpose of this study was to review reports of tramadol and hypoglycemia in the Food and Drug Administration Adverse Event Reporting System (FAERS) database to determine a potential association. Methods: Disproportionality analysis with Bayesian correction was used to compare tramadol and hypoglycemia with other medications in FAERS. The results were considered significant if the fifth percentile of the Empirical Bayesian geometric mean distribution (EB05) >2. Logistic regression odds ratios was used to determine if age, diabetes medications, and renal insufficiency masked the disproportionality of hypoglycemia, with the fifth percentile of the logistic regression odds ratio (LR05) >2 indicating a potential signal. The Interaction Signal Score (INTSS) was computed to determine the influence of predisposing risk factors on the signal. Results: A total of 605 cases of tramadol-associated hypoglycemia were reported, but our results were not significant (EB05: 1.590). Tramadol-associated hypoglycemia was significant in patients who did not take diabetes medications (EB05: 2.256; LR05: 2.2104). Renal insufficiency was not found to increase the risk of tramadol-associated hypoglycemia (INTSS: 0.865). There was a significant signal for tramadol-associated hypoglycemia in patients aged 0 to 1 year (LR05: 3.0240) and 2 to 4 years (LR05: 2.6853). Conclusion and Relevance: Results of our analysis suggest a potential signal between hypoglycemia and tramadol use in patients not taking diabetes medications. Our results do not support a predisposition for tramadol-associated hypoglycemia in patients with renal insufficiency, increasing age, and/or diabetes as noted in the tramadol package insert.

DOI

https://doi.org/10.1177%2F1060028019885643

Comments

This is the author's manuscript version of the article. It is restricted to non-commercial and no derivative uses. It was published in its final form as:

Juba, K. M., van Manen, R. P., & Fellows, S. E. (2019). A Review of the Food and Drug Administration Adverse Event Reporting System for Tramadol-Related Hypoglycemia. Annals of Pharmacotherapy. https://doi.org/10.1177/1060028019885643

Publication Information

Juba, Katherine; Van Manen, Robbert; and Fellows, Shawn E. (2019). "A Review of the Food and Drug Administration Adverse Event Reporting System for Tramadol-Related Hypoglycemia." Annals of Pharmacotherapy 54.3, 247-253.

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