US FDA approves new antibacterial drug Avycaz

The most common side effects include vomiting, nausea, constipation and anxiety

The US Food and Drug Administration (US FDA) has approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor.

Edward Cox, Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research said, “It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”

The most common side effects include vomiting, nausea, constipation and anxiety. Health care professionals should inform patients of these risks and also advise that decreased efficacy, seizures and other neurologic events were seen in patients with poor kidney function (renal impairment). Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

Avycaz is distributed by Forest Pharmaceuticals, a subsidiary of Forest Laboratories based in Cincinnati, Ohio.

AvycazceftazidimeUS Food and Drug Administration