FDA Decision to Treat Omniscan, Other Gadolinium Contrast Dyes Equally QuestionedOct 16, 2009 | Parker Waichman LLP A ProPublica investigation has found that a disproportionate number of Nephrogenic Systemic Fibrosis (NSF) cases have been associated with the use of General Electric's (GE) Omniscan gadolinium contrast dye. Yet, according to the investigation, published in Business Week, the Food & Drug Administration (FDA) has refused to characterize Omniscan as more problematic than its competitors.
Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. These dyes include: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; Magnevist by Bayer/Schering AG/Berlex; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics.
NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. NSF is a relatively new disease. In fact, the first known diagnosis of NSF only occurred in 1997, but it wasn’t until September 2000 that details of the disease were published in the medical journal Lancet.
It appears that NSF only develops in people with pre-existing kidney disease. In 2006, Dutch researchers were the first to link NSF with the use of gadolinium contrast dyes. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.
Since the 2007 warning, hundreds of NSF victims have sued the makers of gadolinium contrast dyes over their injuries. Of 400 lawsuits currently pending in a Multidistrict Litigation, ProPublica says all but about 100 involve Omniscan. Of the 300 that name Omniscan, 70 percent do so exclusively. That's strange when you consider that Omniscan is just the second biggest player in the market. According to ProPublica, Bayer HealthCare has some 50 percent of the U.S. market, while GE is next, with about 30 percent.
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.
Considering the strong correlation between Omniscan and NSF, some have criticized the FDA's stance. Dr. Emanuel Kanal, a professor at the University of Pittsburgh Medical Center, told ProPublica that the FDA's decision was "inappropriate and indefensible," and "endangers American citizens". ProPublica was also quick to point out that Kanal was not working for any parties involved in NSF lawsuits.
Kanal also criticized GE for actions it took after the 2007 blanket warning was issued. At that time, the company reinstated requirements that customers purchase certain minimum amounts of Omniscan in order to receive financial incentives. According to ProPublica, Kanal confronted GE managers over what he considered their "inappropriate" decision to induce customers to buy Omniscan.
According to ProPublica, the FDA has defended its decision on the 2007 gadolinium contrast warning. However, the agency said it would meet with Kanal to look at new data.