An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic

An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic

Opal Steven; File Thomas M; van der Poll Tom; Tzanis Evan; Chitra Surya; McGovern Paul C

Clinical Infectious Diseases: An Official Publication Of The Infectious Diseases Society Of America

2019

2019-08

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.

COMMUNICABLE diseases; community-acquired bacterial pneumonia; COMMUNITY-acquired pneumonia; DENTAL discoloration; omadacycline; PATIENT safety; safety; skin and skin structure infections; SKIN diseases; TEETH abnormalities; TETRACYCLINE; THERAPEUTIC use

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S40-S47

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