Reports find increased risk of NSF with Omniscan
Reports from several scientific and legal sources indicate that Omniscan, the most widely used brand of gadolinium MRI contrast dye, may be more dangerous to patients than others that are on the market. Contrast dyes containing gadolinium are used during MRI exams to help doctors view the brain and other parts of the body.
In May 2007, the Food and Drug Administration required the manufacturers of all gadolinium contrast dyes to add a black box warning about the risk of a condition known as nephrogenic systemic fibrosis (NSF). This condition, which effects patient with kidney problems, may cause thickening of the skin and other tissues, and can be fatal.
According to several studies, Omniscan may be even more dangerous than other gadolinium dyes on the market. A March 2007 study by the American College of Radiology determined that Omniscan created a greater risk of NSF than rival products. Other studies have found that Omniscan has been linked to a disproportionate number of NSF cases compared with other gadolinium MRI contrast dyes. Approximately 70% of the lawsuits filed over these products involved patients who were treated with Omniscan.
Despite findings by FDA scientists that Omniscan was riskier than other gadolinium dyes, the agency has not publicly acknowledged the increased risks that have been linked to the product. However, the FDA indicates that it is planning to meet with a leading imaging safety expert in order to review data about the side effects associated with Omniscan.