Yesterday the makers of MRI contrast agents containing gadolinium announced the language of a “black box” warning they have added to the labels of their products. They also released a letter which was sent to healthcare providers notifying them of the risk of nephrogenic systemic fibrosis among those with kidney problems. This finalizes the warnings which the FDA requested in May 2007.
>>INFORMATION: MRI Contrast Kidney Problems
The warning indicates that when gadolinium-based MRI contrast agents are given to those with kidney problems or liver conditions, it may lead to a serious and potentially fatal condition known as nephrogenic systemic fibrosis (NSF).
There are five different types of contrast agents used during MRIs and MRAs which contain gadolinium:
- Omniscan (gadodiamide) manufactured by General Electric Company’s GE Healthcare
- Magnevist (gadopentetate dimeglumine) manufactured by Bayer AG’s Bayer Schering Pharma
- OptiMARK (gadoversetamide) manufactured by Tyco International Ltd’s Mallinckrodt unit
- MultiHance (gadobenate dimeglumine) and ProHance (gadoteridol) manufactured by Bracco Diagnostics Inc.
NSF is a serious and painful medical condition which leads to excessive formation of connective tissue in the skin and internal organs. It often appears as a hardening and thickening of the skin, primarily on the arms, legs or trunk. The fibrosis causes severe limitations of the movement of the joints and in some cases it can lead to death.
The gadolinium boxed warning states:
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- Acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2), or
- Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/o laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.
The FDA has received reports of over 250 individuals who developed NSF after receiving the MRI contrast. However, most expect that number to drastically increase as more physicians become aware of the symptoms and recognize the condition in their patients. It is generally believed that the number of FDA reported adverse effects associated with medical products is between 1% and 10% of the true number of cases.
According to the FDA, there have been no reports of NSF among those with normal kidney function or those with only mild kidney insufficiencies. The letter from the manufacturers estimates that the risk of developing NSF among those with severe kidney problems is about 4%.
The gadolinium lawyers at Saiontz & Kirk, P.A. represent individuals diagnosed with nephrogenic systemic fibrosis, previously known as nephrogenic fibrosing dermopathy. The gadolinium contrast agents are the only known cause for this condition, and the manufacturers previously failed to provide adequate warnings about this potential problems for those with kidney insufficiencies. If you, a friend or family member suspect that you may qualify for a gadolinium lawsuit, request a free claim evaluation.