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. 2019 Aug 1;69(Suppl 1):S40-S47.
doi: 10.1093/cid/ciz398.

An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic

Steven Opal  1 , Thomas M File  2   3 , Tom van der Poll  4   5 , Evan Tzanis  6 , Surya Chitra  6 , Paul C McGovern  6
Affiliations

An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic

Steven Opal et al. Clin Infect Dis. .

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.

Keywords: community-acquired bacterial pneumonia; omadacycline; safety; skin and skin structure infections.

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Figures

Figure 1.
Figure 1.
Mean changes in heart rate (beats per minute [bpm] ± standard error of the mean) from baseline. The mean heart rate changes from baseline on day 1 and day 2 for OASIS-1 and OPTIC demonstrate an approximate mean change in heart rate of 5 bpm after the first dose on day 1 for omadacycline. Abbreviations: ABSSSI, acute bacterial skin and skin structure infection; CABP, community-acquired bacterial pneumonia; D, day; EOT, end of treatment; OASIS, Omadacycline in Acute Skin and Skin Structure Infections Study; OPTIC, Omadacycline for Pneumonia Treatment In the Community.
See this image and copyright information in PMC

References

    1. Villano S, Steenbergen J, Loh E. Omadacycline: development of a novel aminomethylcycline antibiotic for treating drug-resistant bacterial infections. Future Microbiol 2016; 11:1421–34. - PubMed
    1. Draper MP, Weir S, Macone A, et al. . Mechanism of action of the novel aminomethylcycline antibiotic omadacycline. Antimicrob Agents Chemother 2014; 58:1279–83. - PMC - PubMed
    1. Nelson ML, Levy SB. The history of the tetracyclines. Ann N Y Acad Sci 2011; 1241:17–32. - PubMed
    1. Sloan B, Scheinfeld N. The use and safety of doxycycline hyclate and other second-generation tetracyclines. Expert Opin Drug Saf 2008; 7:571–7. - PubMed
    1. O’Riordan W, Green S, Overcash JS, et al. . Omadacycline for acute bacterial skin and skin-structure infections. N Engl J Med 2019; 380:528–38. - PubMed

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