FDA approves Bayer’s imaging agent Ultravist for use in contrast-enhanced mammography

The U.S. Food and Drug Administration has approved Bayer’s imaging agent Ultravist for use in contrast-enhanced mammography, the company announced Friday.

It is an iodine-based injectable used to help radiologists visualize lesions of the breast in adults, also serving as an adjunct to ultrasound. The Germany-based corporation (with U.S. offices in Whippany, New Jersey) said this is the “only contrast agent approved for this indication” in America.

“The approval of Ultravist [iopromide]-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” Konstanze Diefenbach, MD, head of radiology research and development at Bayer, said in a June 23 announcement. “We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear answers from diagnosis to care for patients.”

Contrast-enhanced mammography has shown promise in helping visualize breast tissue lesions, with Ultravist adding a “relatively low-cost” option during imaging examinations, Bayer noted. Providers can use the agent across various clinical settings and scenarios, including when routine scans produce inconclusive findings or if breast MRI is unavailable or contraindicated.

Common adverse reactions to Ultravist—occurring in about 1% of patients—included headache, nausea, injection site reactions, vomiting, back pain, urinary urgency and abnormal vision, among others. You can find the full prescribing information for the drug here.

Editor's note: This article has been updated to clarify that Ultravist is not a new imaging agent and is only being approved for a new indication.