The U.S. Food and Drug Administration approved Tuesday the MRI contrast agent gadobutrol, marketed as Gadavist by Bayer Pharmaceuticals of Wayne, N.J.

Gadavist, the sixth gadolinium-based contrast agent approved by the agency, helps visualize the central nervous system. The FDA said it could help doctors detect lesions that disrupt the blood-brain barrier and also find blood supply and circulation problems.

"Gadavist MRI scans improved the visualization of lesions in the central nervous system when compared to MRI scans without contrast," Dr. Libero Marzella, acting division director, Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Approval of the drug, cleared for patients over 2 years of age, is based on two clinical studies involving 657 patients.

Gadavist's dose to patients is the same as most gadolinium-based contrast agents, 0.1 mmol/kg, but it is twice as concentrated, and should be administered at half the volume, the FDA said.

Like other drugs in its class, Gadavist carries a black box warning for nephrogenic systemic fibrosis (NSF), an extremely rare but potentially fatal condition associated with the use of gadolinium-based contrast agents among patients with kidney problems. However, the FDA opted to give it a lower-risk classification for NSF, saying it was "not one of the GBCAs that is contraindicated in patients with acute kidney injury or chronic, severe kidney disease."

The watchdog agency said headache and nausea were the most common side effects of the drug. But other adverse events associated with the drug include "hypersensitivity" reactions.

In Europe, Gadavist, known as Gadovist, is approved to enhance imaging of blood vessels, the brain, spine, liver and kidney. In January, Bayer said it got approval to use the drug in children over seven in most of Europe's main markets, such as Germany.

The drug was first approved for use in 1998, and is currently available in around 50 countries, the company said.

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