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New FDA warnings for contrast agents

The US Food and Drug Administration is requiring new warnings for three contrast agents used in body scans

The US Food and Drug Administration (FDA) is requiring new warnings for three contrast agents used in MRIs and other body scans: Bayer Healthcare's Magnevist (gadopentetate dimeglumine), GE Healthcare's Omniscan (gadodiamide), and Covidien's Optimark (gadoversetamide injection).

The intravenous products, which have been linked to a rare, life-threatening fatal condition called nephrogenic systemic fibrosis (NSF) in certain patients with kidney disease, will now be labelled inappropriate for use among patients with acute kidney injury or chronic severe kidney disease.

In addition, all products in the class of drugs – gadolinium-based contrast agents (GBCA) – will carry new warnings on their labels about the potential risk of NSF if the drug is administered to certain patients with kidney disease and will emphasise the need to screen patients to detect these types of kidney dysfunctions before administration.

The level of NSF risk associated with the products has been the subject of debate for a number of years and has already led to multiple lawsuits. About 500 suits have been filed by NSF patients against GE, some of them alleging that the company concealed information from the FDA and fought against changing the labelling and usage of the drug even after its own safety experts urged the change in internal meetings.

NSF is a condition in which excess fibrous connective tissue forms in the skin, joints, eyes, and internal organs. It can be fatal if it leads to hardening of the organs.

While the FDA's safety review determined that Magnevist, Omniscan and Optimark are associated with a greater risk than other GBCAs, the agency will continue to assess the entire class of drugs in order to better estimate each product's risk.

14th September 2010

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