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Gov't Panel seeks Blackbox Warning for MRI Drugs

MRI imaging drugs from GE Healthcare (GE.N) and Covidien (COV.N) appear linked to a higher risk of a potentially fatal skin disease for some patients than similar products.

'A majority of the Food and Drug Administration panel felt current data showed GE's Omniscan and Covidien's Optimark were associated with a higher risk of nephrogenic systemic fibrosis (NSF) for patients with severe kidney disease, panel chairman Robert Harrington said.' Source.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

A black box warning is a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects. This warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency which oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

When a drug receives a black box warning, it means that studies on the drug have suggested that it can have dangerous or even deadly side effects. Black box warnings are often added retrospectively as the result of information about a drug which has been uncovered in the course of routine usage. When doctors start reporting high levels of dangerous side effects for a prescription drug, the FDA may hold a review to decide whether or not the drug requires a black box warning.

The ?black box? in ?black box warning? refers to the bold black border which is drawn around the warning. The border is designed to draw attention to the warning, and to offset it from other information which may be present in pharmaceutical packaging. Thanks to widespread public awareness of the implications of a black box warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text of the warning.

Full post as published by A Georgia Lawyer on December 31, 2009 (boomark / email).