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An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic

Steven Opal1, Thomas M File2,3, Tom van der Poll4,5

  • 1Warren Alpert Medical School of Brown University, Providence, Rhode Island.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|August 2, 2019
PubMed

Insights

Omadacycline, a novel tetracycline antibiotic, demonstrates an acceptable safety profile for treating skin infections and pneumonia. Common side effects like nausea were generally not limiting, though specific warnings apply to pediatric use and pregnancy.

Area of Science:

  • Pharmacology
  • Infectious Diseases
  • Clinical Trials

Background:

  • Omadacycline is a novel, semisynthetic tetracycline antibiotic.
  • Tetracyclines are a class of broad-spectrum antibiotics used to treat various bacterial infections.

Purpose of the Study:

  • To evaluate the safety and tolerability of omadacycline in Phase III clinical trials.
  • To assess the efficacy of omadacycline in treating acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Main Methods:

  • Phase III clinical trials were conducted to assess omadacycline's safety and efficacy.
  • Adverse events, laboratory changes, and specific warnings were documented during the trials.

Main Results:

  • Omadacycline exhibited an acceptable safety profile in patients with ABSSSI and CABP.
  • The most frequent adverse events were transient nausea, vomiting, and minor increases in liver aminotransferases, which were not treatment-limiting.
  • Specific warnings include potential tooth discoloration, enamel hypoplasia, and inhibition of bone growth in young children and during pregnancy. An imbalance in mortality was observed in the CABP study.

Conclusions:

  • Omadacycline is a potentially valuable therapeutic option for ABSSSI and CABP, with a generally manageable safety profile.
  • Healthcare providers must carefully consider the established warnings and precautions, particularly regarding use in pediatric populations and pregnant women.
Keywords:
community-acquired bacterial pneumoniaomadacyclinesafetyskin and skin structure infections

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