subject: Fda: Some Mri Drugs Cause Skin Problems In Kidney Patients [print this page] Magnetic resonance imaging (MRI) pharmaceuticals produced by GE Healthcare and Covidien pose a higher risk of developing the potentially fatal skin disease Nephrogenic Systemic Fibrosis, according to a recent Food and Drug Administration panel.
Because of the element gadolinium makes MRI scans easier to read, the medications have been used in millions of patients worldwide, despite the element's association with the onset of Nephrogenic Systemic Fibrosis (NSF), a rare skin disease that causes thickening of the internal organs, body tissues and skin in individuals who develop the disease. Patients suffering from advanced cases find it difficult to move due to the disease, which has resulted in difficulty breathing or broken bones. Studies have shown that many NSF patients were exposed to the element gadolinium at least three months prior to NSF onset, however the exact cause of the disease is unclear. Patients with advanced kidney disease are more at risk of developing the potentially fatal skin disease. 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. Many individuals, health care professionals and family members feel this warning is insufficient due to the increased risk of NSF. 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 formally required additional warnings, however the Administration is evaluating input received from the advisers.
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. The pharamaceutical companies have not admitted that some GCBAs pose an increased risk of resulting in NSF, yet all have agreed to cooperate with the FDA about the best course of action.
