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MRI Health Risks Lead the FDA to Reconsider Rules on Imaging Drugs

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New York, NYAn FDA advisory panel is set to convene next week to determine whether new regulations may be required for three imaging drugs that contain the chemical gadolinium, a compound that poses significant MRI health risks.

The three drugs, which allow for a more thorough image of a body when injected in patients prior to MRI scans, have been associated with nephrogenic systemic fibrosis. NSF is a debilitating and potentially fatal syndrome in which an excessive amount of collagen forms in joints, skin and organs leading to potential paralysis, lung embolisms and eventually death.

According to Business Week, more than 500 lawsuits to date have been filed against makers of drugs containing gadolinium in the US, prompting many major hospitals to discontinue use of the products.

In 2006 the FDA began grouping all imaging products that use gadolinium in one class, claiming in, "There is no definitive evidence establishing that the risk of acquiring NSF is greater for one agent than for the others in the class."


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