TY - JOUR
T1 - An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic
AU - Opal, Steven
AU - File, Thomas M.
AU - van der Poll, Tom
AU - Tzanis, Evan
AU - Chitra, Surya
AU - McGovern, Paul C.
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85070879358&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31367740
U2 - https://doi.org/10.1093/cid/ciz398
DO - https://doi.org/10.1093/cid/ciz398
M3 - Article
C2 - 31367740
SN - 1058-4838
VL - 69
SP - S40-S47
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 1
ER -