FDA Approves New Option for Complicated UTIs

Fetroja (cefiderocol) was approved by the US Food and Drug Administration (FDA) for adult patients with complicated urinary tract infections (cUTIs), including those with limited or no alternative treatment options.

Fetroja is an antibacterial drug that was proven safe and effective in a study of 448 patients with cUTIs.

The most common adverse effects reported by patients taking fetroja included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion site reactions, candidiasis, cough, headache, and hypokalemia.

The FDA warns that fetroja should not be prescribed to individuals with a known history of severe hypersensitivity to β-lactam antibacterial drugs.

“Today’s approval provides an additional treatment option for patients with cUTIs who have limited or no alternative treatment options,” said John Farley, MD, MPH, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections.”

—Amanda Balbi


FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance [press release]. Silver Spring, MD; US Food and Drug Administration: November 14, 2019. Accessed November 15, 2019.