FDA Warning -Defective Product

Greg Owen

Attorney

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Many people have had an MRI with and MRI scan comes a gadolinium-based contrast agent, which are used to enhance the quality of magnetic resonance imaging (MRI). The Food and Drug Administration (FDA) first notified health care professionals and the public about the gadolinium-related risks for nephrogenic systemic fibrosis NSF in June 2006 . Information regarding those risks were updated in December 2006. Now manufacturers have been asked by the FDA to include a new warning on all gadolinium-based contrast agents, which are used to enhance the quality of magnetic resonance imaging (MRI).

Not everyone is at risk. However, individuals who have severe kidney disease are at risk of developing NSF. Additionally, individuals who are pre or post liver transplantation, or who have chronic liver disease also run a risk of developing NSF. The disease is a serious one. NSF causes thickening of the skin and connective tissues, which causes an inability to move.

Individuals should be screened for the above-noted illnesses prior to receiving an imaging agent. There have been no reports of NSF among individuals who have normal kidney & liver function. Nor have there been reports of NSF among those with mild-to-moderate kidney insufficiency. One should always be mindful of potential defective products, particularly one that can cause extensive permanent physical damage.