New Combo Antibacterial Approved for Complicated Intra-Abdominal Infections, UTIs

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA has approved a new combination antibacterial — ceftazidime-avibactam — marketed as Avycaz. The cephalosporin/beta-lactamase inhibitor combination is indicated for adults with complicated intra-abdominal infections (used with metronidazole) and complicated urinary tract infections.

Approval was based on previous ceftazidime studies and data from in vitro studies and animal models of avibactam. The antibacterial combination was also studied in two phase II trials (one for complicated intra-abdominal infections and one for complicated UTIs).

The FDA warns that patients with renal impairment could be at risk for adverse neurologic events (e.g., seizures). Common side effects include anxiety, constipation, nausea, and vomiting.