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Gadolinium Contrast Dyes FDA Advisory Panel Review Next Week

Dec 1, 2009 | Parker Waichman LLP
Gadolinium Contrast

U.S. Health Regulators are Set to Review Gadolinium Contrast Dyes this Month.

U.S. health regulators are set to review gadolinium contrast dyes this month.  The Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee  will meet on December 8 to review data from gadolinium contrast manufacturers to, among other things, differentiate the risk of nephrogenic systemic fibrosis (NSF) between gadolinium agents, and provide the agency guidance on labeling.

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. They are: OptiMARK, by Covidien Inc., Prohance and Multihance, both by Bracco Diagnostics, Bayer Healthcare’s Magnevist and GE Healthcare’s Omniscan.

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.

It appears that NSF only develops in people with pre-existing kidney disease. 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.

Black Box warning, the FDA has continued to collect data on Gadolinium Contrast Dyes and NSF.

Since the 2007 black box warning, the FDA has continued to collect data on gadolinium contrast dyes and NSF.  According to documents released last month by the FDA, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMARK. The lowest risk was associated with Prohance and Multihance. However, the agency said “the data do not appear to rule out an NSF risk for each of the agents.” FDA reviewers said the extent of risk from any of the agents was unknown. One study of Omniscan estimated the chances of developing NSF was 4 percent among patients with severe kidney impairment.

Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product.

That issue will be addressed at the December 8 advisory panel meeting.  However, as we previously reported, Covidien has already decided to modify the label of OptiMark to contraindicate its use in patients with severe kidney impairment because of its association with NSF.  At the time, a spokesperson for the company told Reuters that “it was prudent to act now, rather than wait for a causal link… to be established” between the imaging drugs and NSF.

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