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Restrict Some Gadolinium Contrast Dyes, FDA Panel Says

Dec 8, 2009 | Parker Waichman LLP

Use of some Gadolinium Contrast Dyes should be restricted because of their Association with NSF

The use of some gadolinium contrast dyes should be restricted because of their association with nephrogenic systemic fibrosis (NSF), according to a recommendation just made by a Food & Drug Administration (FDA) advisory panel.  

Reuters is reporting that the panel supported new warnings for General Electric's  Omniscan and Covidien Inc.'s OptiMark that say they should not be used in patients with severe kidney disease. The panel felt that Omniscan and OptiMark. along with Bayer's Magnevist, appeared to carry  a higher NSF risk than similar products. The recommendation represented a "preponderance of opinion" on the panel,  and not a formal vote, Reuters said.

Meanwhile, Dow Jones News Service is reporting that the same FDA panel also recommended restricting the use of Magnevist to patients without kidney severe kidney disease.  However, according to Reuters, there was less consensus on the panel in regards to Magnevist.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does so.

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.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies.  It appears that NSF only develops in people with pre-existing kidney disease. In 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about their association with NSF.  Since the warning, the FDA and the makers of gadolinium contrast dyes have continued to collect data about their association with NSF.

The Highest Risk of NSF was Associated with Omniscan, Magnevist and OptiMark.

According to documents released last month by the FDA in advance of today's meeting, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMark. The lowest risk was associated with Prohance and Multihance, both marketed by Bracco Diagnotics.   However, the FDA was unable to rule out a risk for any of the agents.

FDA staff said it was too early to reach conclusions about Bayer's Eovist and Lantheus Medical Imaging's Ablavar, two recently approved gadolinium agents.

According to Dow Jones, at today's FDA advisory panel meeting, radiologists said that clinicians have essentially stopped using gadolinium agents  in  patients with severe kidney disease.  The panel was also told that reports of NSF have  dropped significantly since the black box warning was mandated.

Last month, Europe's health regulatory agency said Omniscan, Magnevist and OptiMark  shouldn't be used in patients with severe kidney problems.

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.

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Need Legal Help Regarding Restrict Some Gadolinium Contrast Dyes

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