The U.S. Food and Drug Administration said Thursday that certain types of drugs used in MRI scans shouldn’t be used in patients with kidney disease because of the risk of developing a rare and potentially fatal skin condition.
The FDA said that drugs known as gadolinium-based contrast agents will carry new warnings on their labels about the risk of nephrogenic systemic fibrosis if the drugs are administered to certain patients with kidney disease. The drugs are also used in a procedure known as magnetic resonance angiography, or MRA.
The agency also said that three of the drugs should be avoided in patients with kidney disease—Covidien PLC’s Optimark, Bayer AG’s Magnevist and General Electric Co.’s Omniscan. There are seven gadolinium-based contrast agents and they are used to help detect problems with body organs, blood vessels and other tissues.
The FDA said its review of the safety of the drugs determined that Magnevist, Omniscan and Optimark are associated with a greater risk than the other drugs for nephrogenic systemic fibrosis in certain patients with kidney disease. NSF is a condition marked by the formation of excess fibrous connective tissue in the skin, joints, eyes and internal organs, and it can be fatal. The FDA said no cases of NSF have been reported among patients with normal kidney function.
Last November, Covidien had said it would voluntarily contraindicate the use of Optimark in kidney-disease patients.
In a statement, GE Healthcare said it would update Omniscan’s label as requested by the FDA. The company said Omniscan and similar drugs “continue to be a valuable diagnostic tool with a proven safety record for the overwhelming majority of patients to whom they are prescribed.”
Bayer Healthcare said it received the FDA’s request for a new label on Magnevist and another product, Eovist. The company said it would respond to the FDA within the 30 days allowed in the letter.
“Patient safety is Bayer’s primary concern, and the company is committed to the appropriate and safe use of its products,” the company said.
The agency said all patients should be screened prior to being given a gadolinium-based drug to identify people with acute kidney injury, or chronic or severe kidney disease.
The Wall Street Journal