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Descriptive Analysis of Adverse Events Reported Associated with the Use of Tigecycline or Minocycline Using the FDA Adverse Event Reporting System Database from 2008 to 2021

Speaker(s)

Almadfaa R1, Hincapie AL2, Guo JJ3
1University of Cincinnati, Cincinnati, OH, USA, 2University of Cincinnati, James L. Winkle College of Pharmacy, Cincinnati, OH, USA, 3James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, USA

Presentation Documents

Introduction: To overcome bacterial resistance, more potent antibiotics with broader spectrum of activity were discovered like tigecycline, which is a minocycline derivative. However, the current literature suggests the need for an investigation regarding the occurrence of adverse events with minocycline and tigecycline. This study aimed to explore the frequency of adverse events associated with the use of minocycline and tigecycline from the FDA adverse events reporting system (FAERS) database.

Method: a retrospective study based on the FAERS database that descriptively analyzes all adverse events reports associated with the use of tigecycline or minocycline from 2008 to 2021. This includes congenital anomaly, death, disability, life-threatening condition, and Required Intervention.

Results: We found 251,724 adverse events reported between the first quarter of 2008 to the second quarter of 2021 associated with the use of minocycline and tigecycline from 234,369 patients. The main adverse events reported were drug-related issues, musculoskeletal, dermatological, blood and coagulation, pain and discomfort, nausea and/or vomiting, and respiratory system AEs. The FAERS database had a total of 150235 outcomes associated with the use of minocycline and tigecycline. Of these outcomes, hospitalization accounted for the highest percentage (27.99%), followed by death and life-threatening (9.77% and 6.46 % respectively).

Conclusion: Drug-related and musculoskeletal AEs were the most reported ADEs associated with tigecycline and minocycline use. Hospitalization and death were the highest reported outcome associated with use of study drugs. More pharmacoepidemiology research is warranted to validate the drug-event association.

Code

EPH66

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Infectious Disease (non-vaccine)