Journal
CLINICAL INFECTIOUS DISEASES
Volume 69, Issue -, Pages S40-S47Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciz398
Keywords
omadacycline; safety; community-acquired bacterial pneumonia; skin and skin structure infections
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Funding
- Paratek Pharmaceuticals, Inc.
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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 M-2 receptors resulted in transient heart rate increases following dosing.
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