FDA Approves New Antibacterial Agent for Complicated UTIs, Complicated IAIs

Recarbrio (imipenem, cilastatin, and relebactam) has been approved by the US Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and complicated intra-abdominal infections in adults.

Recardrio is a 3-drug antibacterial drug injection containing an FDA-approved antibiotic and a new β-lactamase inhibitor.

The most common adverse reactions reported in studies of recardio were nausea, diarrhea, headache, fever and increased liver enzymes.

“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”

—Amanda Balbi

Reference:

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections [press release]. Silver Spring, MD: US Food and Drug Administration; July 17, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-complicated-urinary-tract-and-complicated-intra-abdominal-infections?utm_campaign=07172019_PR_FDA%20approves%20treatment%20for%20complicated%20UTI%20and%20complicated%20IAI. Accessed July 17, 2019.