FDA Approves New Combination Antibiotic Avycaz

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FDA Approves New Combination Antibiotic Avycaz
FDA Approves New Combination Antibiotic Avycaz

(HealthDay News) -- The combination antibiotic Avycaz (ceftazidime-avibactam) has been approved by the U.S. Food and Drug Administration to treat adults with complicated infections of the intra-abdominal area or urinary tract, including the kidneys.

Avycaz contains the previously approved antibiotic ceftazidime, and the newer antibacterial drug avibactam, the agency said in a news release. Approved to help combat antibacterial resistance, Avycaz is sanctioned for people who have limited or no other treatment options, the FDA said.

The most common side effects identified during clinical testing included vomiting, nausea, constipation, and anxiety. Users with poor kidney function had more serious adverse reactions, including decreased effectiveness and seizures. And users allergic to penicillin may be at greater risk of serious skin reactions and anaphylaxis, the FDA warned.

"The FDA is committed to making therapies available to treat patients with unmet medical need," Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."

Avycaz is distributed by Actavis, based in Cincinnati.

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