An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Steven OpalPaul C McGovern

Abstract

Omadacycline is a semisynthetic tetracycline antibiotic. Phase III clinical trial results have shown that omadacycline has an acceptable safety profile in the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Similar to most tetracyclines, transient nausea and vomiting and low-magnitude increases in liver aminotransferases were the most frequent treatment-emergent adverse events in phase III studies but were not treatment limiting. Package insert warnings and precautions for omadacycline include tooth discoloration; enamel hypoplasia; inhibition of bone growth following use in late pregnancy, infancy, or childhood up to 8 years of age; an imbalance in mortality (2%, compared with 1% in moxifloxacin-treated patients) was observed in the phase III study in patients with community-acquired bacterial pneumonia. Omadacycline has no effect on the QT interval, and its affinity for muscarinic M2 receptors resulted in transient heart rate increases following dosing.

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Citations

Aug 2, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Jason C Gallagher
Nov 28, 2019·Clinical Pharmacokinetics·Keith A RodvoldManjunath P Pai
Jan 24, 2020·Drugs·George G ZhanelJames A Karlowsky
Oct 24, 2020·Open Forum Infectious Diseases·Jeffrey C PearsonSigal Yawetz
Dec 9, 2020·Antimicrobial Agents and Chemotherapy·Barbara A Brown-Elliott, Richard J Wallace
Mar 23, 2021·Clinical Pharmacokinetics·Jan-Willem AlffenaarCharles A Peloquin
Jan 28, 2021·Medicinal Research Reviews·Laiying ZhangYoufu Luo

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Clinical Trials Mentioned

NCT02378480
NCT02877927
NCT02531438

Software Mentioned

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