Restrict Use of Gadolinium Contrast Agents, FDA Panel Says

The use of gadolinium contrast agents during medical imaging scans should be restricted because of an apparent link to a potentially fatal skin-hardening disease, a Food and Drug Administration advisory panel has ruled, according to a CNNmoney.com report.

The agents should only be used on patients without severe kidney problems because they can cause nephrogenic systemic fibrosis (NSF), a progressive disease which results in thickening and hardening of the skin, particularly in the arms, legs and other extremities.

Omniscan, Magnevist, and Optimark are among seven FDA-approved products containing gadolinium that are used to enhance images when patients undergo magnetic resonance imaging (MRI) or similar procedures. Hundreds of reports of NSF have been reported in patients with severe kidney disease following MRI scans using the gadolinium dyes. European health advisors said in November that Omniscan, Magnevist, and Optimark shouldn’t be used in patients with severe kidney problems.

3 Brands Associated With Greatest Risks

Omniscan (GE Healthcare), Magnevist (Bayer Schering Pharma), and Optimark (Covidien) are associated with the highest risks of NSF, the FDA has said. Two other brands of gadolinium contrast agents, ProHance and MultiHance, are made by Bracco Diagnostics and carry the lowest risks of the skin disease.

The labels for the products were updated by the FDA in 2006 to warn that using them in patients with severe kidney disease may cause NSF. The number of reports of NSF in patients exposed to the dyes has dropped since that 2006 warning, officials said.

In May 2007, the FDA again asked manufacturers of gadolinium-based contrast agents to include additional warnings on the products’ labeling to alert patients with severe kidney insufficiency about the risk of developing NSF.

The FDA is not required to accept the advice of its expert panels, but most of the time, it does. It is unclear what changes the FDA will take with regards to gadolinium contrast dyes in the future.

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