Medical Device:

FDA Gadolinium Warnings

The FDA has issued three warnings about the side effects of Gadolinium between June 2006 and May 2007. The initial warning concerning gadolinium occurred after a Dutch study linked gadolinium with nephrogenic systemic fibrosis (NSF). This potential deadly disease, also known as nephrogenic fibrosing dermopathy (NSD), has been found in patients with pre-existing kidney conditions who have undergone a MRI or MRA using a gadolinium contrast agent. The FDA eventually issued a black box warning, its strongest warning, for gadolinium contrast agents, including Omniscan, Magnevist, OptiMARK, ProHance and MultiHance. This warning alerts those with kidney conditions to the possibility of developing nephrogenic systemic fibrosis after being injected with gadolinium before a MRI. If you or a loved one has a developed nephrogenic systemic fibrosis, contact a gadolinium lawyer immediately.

June 2006 Gadolinium Wanring

In June 2006, the FDA released the first of three warnings about the MRI contrast dye gadolinium. The FDA was alerted of gadolinium’s risks after a Dutch study discovered that gadolinium-containing contrast dyes have been linked to several cases of nephrogenic systemic fibrosis, or nephrogenic fibrosing dermopathy. Three gadolinium brands, comprising of Omniscan, Magnevist and OptiMark, had been linked to the onset of the potentially deadly nephrogenic systemic fibrosis. The FDA warned doctors to screen patients for kidney conditions before using gadolinium in MRIs. The FDA advised that gadolinium contrast agents, especially high doses of the drug, should only be used if absolutely necessary in those with advanced kidney failure.

December 2006 Warning for Gadolinium

In December 2006, the FDA released its second of three warnings about the MRI contrast agent gadolinium. By this time, the FDA received approximately 90 reports of patients with moderate to severe kidney conditions who had developed nephrogenic systemic fibrosis (NSF) after receiving a gadolinium-based injection during an MRI. Nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy, is a potentially life-threatening disease that causes fibrosis of the skin, eyes, joints and internal organs. The FDA stated that there were 215 cases of nephrogenic systemic fibrosis worldwide, and of those patients whose medical history were known, all had received a gadolinium injection before the diagnosis. The FDA warned doctors and physicians that those with moderate to advanced kidney disease who received a gadolinium injection before an MRI and MRA may develop the debilitating and possibly deadly nephrogenic systemic fibrosis. The FDA advised that those with severe kidney problems should use other imaging methods and if a patient must received a gadolinium injection, prompt dialysis should follow. The warning also advised patients with nephrogenic systemic fibrosis symptoms, which include tightening and hardening of the skin, should seek immediate medical attention.

May 2007 Gadolinium Warning

The last of the three warnings issued by the FDA about the MRI contrast agent gadolinium occurred in May 2007. The FDA requested that the manufacturers of five gadolinium-containing contrast agents should include a black box warning, the strongest safety warning. This warning would alert patients with kidney problems to the possibility of developing nephrogenic systemic fibrosis (NSF) after being administered a gadolinium injection. The FDA warning advised those at risk for nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy (NFD), should see a doctor to monitor symptoms. Common signs of nephrogenic systemic fibrosis include hardening and tightening of the skin, yellow spots on the whites of the eyes, muscle weakness and inability to extend joints. The FDA also developed a reporting program so instances of nephrogenic systemic fibrosis caused by gadolinium could be reported. The five gadolinium drugs requested to include this safety warning include Magnevist, Omniscan, OptiMARK, ProHance and MultiHance. If you have developed nephrogenic systemic fibrosis after receiving a gadolinium contrast agent during a MRI or MRA, contact a gadolinium attorney immediately.

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