Nephrogenic Systemic Fibrosis Risk With New MRI Contrast To Be Reviewed

The FDA has asked a panel of outside experts to evaluate the risk of nephrogenic systemic fibrosis (NSF) with a new MRI contrasting agent proposed by Bayer AG. 

An FDA advisory committee is meeting today to consider whether to approve gadobutrol, and will consider the potential NSF side effects from the gadolinium contrast agent. Gadobutrol is stronger than other drugs in its class, and the advisory committee will also weigh the risk of overdose with the proposed drug.

Nephrogenic systemic fibrosis (NSF), which is also referred to as nephrogenic fibrosing dermopathy or gadolinium associated systemic fibrosis, is a rare condition that has been linked to exposure to gadolinium-based MRI contrast agents among individuals with impaired kidney function. There is no cure for the painful and debilitating disorder, which causes a hardening and thickening of the skin and may lead to death.

In September 2010, the FDA banned the use of Bayer’s Magnevist on patients with kidney problems due to the risk of NSF. The agency also put similar restrictions on GE Healthcare’s Omniscan and Covidien’s Optimark.

The agency also required label changes to all gadolinium-based contrast agents (GBCAs) warning healthcare professionals to screen patients before injecting a GBCA to identify those suffering from acute kidney injury or chronic, severe kidney disease. GBCAs are solutions that are given to patients before undergoing a magnetic imaging resonance (MRI) scan to improve the results.

FDA staff analysis of gadobutrol found it to have a similar or lower risk of NSF as other GBCAs, according to documents released in advance of the meeting.

Several hundred lawsuits over nephrogenic systemic fibrosis have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Although several manufacturers have reached settlement agreements in cases, the first gadolinium trial is scheduled to begin on Monday involving a case against GE Healthcare over its Omniscan MRI contrasting agent.