A recent Food and Drug Administration panel has found magnetic resonance imaging (MRI) drugs manufactured by GE Healthcare and Covidien appear to be linked to a
higher risk of developing a potentially fatal skin disease called Nephrogenic Systemic Fibrosis.
Although the imaging medications have been used in millions of patients to make MRI scans easier to read, gadolinium, the active element in the medications, is
associated with the onset of Nephrogenic Systemic Fibrosis (NSF), a rare degenerative skin disease that causes thickening of the skin, internal organs and other tissues in those individuals who develop the condition. Advanced cases can make it difficult for
patients to move, which often results in broken bones or difficultly breathing. Although the exact cause is unclear, studies have found that many NSF patients were exposed to gadolinium at least three months prior to diagnosis. NSF is more likely to occur in patients with advanced kidney disease and can be fatal. At this time, no effective treatment has been developed.
The FDA requires that gadolinium-based contrast agents, GBCAs, currently carry a "black box" warning informing health care professionals to avoid prescribing to patients with kidney problems. However, due to the increased risk of NSF, many feel the warning is insufficient. Although the number of NSF cases has dropped since 2007, many individuals who have developed NSF due gadolinium exposure have contacted a NSF lawyer to develop potential and often lengthy Nephrogenic Systemic Fibrosis lawsuit.
Because of the seriousness of the disease, however, the FDA is debating whether the drugs should carry an additional warning stating the increased risk of developing NSF, especially in patients with a history of severe kidney problems.
The most recent FDA panel pointed out that some imaging medications carry a higher risk than others, which makes them hesitant to require all medications to carry an additional warning label. Because the drugs provide an excellent diagnostic tool for patients under going an MRI, some panel members feel labeling medications differently will create a misconception that some drugs are better or worse than others. The FDA has not issued a formal statement requiring additional warnings, although it is currently evaluating the panel advisers' input.
Bayer, Covidien and GE Healthcare are currently involved in NSF lawsuits regarding GBCA medications, however Covidien has voluntarily added an additional warning to its medication, Optimark. All have agreed to work with the FDA on the best course of action regarding the medication, although they are hesitant to admit that some GCBAs carry a higher risk than other medications at causing NSF.
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