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Important Information on Nephrogenic Systemic Fibrosis (NSF)
FDA Criticized on Omniscan Stance
Friday, October 16th, 2009According to a ProPublica investigation, the Food & Drug Administration (FDA) has refused to characterize Omniscan as more problematic than its competitors, even though a disproportionate number of NSF cases have been associated with that particular gadolinium contrast dye.
According to ProPublica, the FDA and GE knew in 2007 that Omniscan was involved in a disproportionate number of NSF reports. But The FDA added the same warning to all gadolinium contrast dies, even though two of its staff doctors had determined that Omniscan is riskier than its rivals. One of the doctors told ProPublica that she had found that medical and sales data indicated Omniscan “had most of the cases and less of a share of the market, so I believed Omniscan was the worst player.” In April 2006, the second doctor told the FDA that “a contraindication for Omniscan is warranted” for patients with severe kidney disease. According to ProPublica, a contraindication would have basically banned the use of Omniscan in those patients.
According to ProPublica, the FDA issued the 2007 warning after GE had urged it to treat all of the gadolinium dyes as equally risky.
