The U. S. Food and Drug Administration (FDA) announced today that it would like manufacturers of all gadolinium-based contrast agents used to enhance MRI images to include a warning label on boxes. The warning label should state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating and potentially fatal disease called Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogrenic Fibrosing Dermopathy (NFD) The label should also state that patients before or after a liver transplant or who have chronic liver disease are also at risk for NSF is they are experiencing kidney insufficiency.
The FDA notified health care professional and the public about the risk factors for NSF in June 2006. More information about the risks was released in December. According to the law firm Saiontz, Kirk & Miles, P.A., class action lawsuits and individual lawsuits are being investigated against the manufacturers of the five gadolinium agents, which are:
MultiHance (gadobenate dimeglumine)
Magnevist (gadopentetate dimeglumine)
Lawyers claim manufacturers failed to properly study the effects of their products on people with improper kidney function, and that they failed to warn patients of the life-altering and potentially fatal problems that could develop when gadolinium is used in the MRI process. Most of the cases involve the use of Omniscan (gadodiamide), however, the lawyers are studying reports that involve people developing problems after using three of the five injections. The FDA has received reports regarding the development of NSF after the use of Magnevist and OptiMARK.
Side effects of the gadolinium agents include:
* burning, itching, swelling, hardening or tightness of the skin that inhibits ability to move resulting in possible broken bones
* red or dark patches on the skin
* yellow spots in the whites of eyes
* pain in ribs and/or hips
* muscle weakness
* thickening of other organs
Gadolinium-based contrast agents are used in the MRI imaging process to enhance the visibility of internal structures in the body. This makes it useful as a contrast “dye” during MRI and MRA, which are done to obtain detailed and clear images of internal organs and vessels. Gadolinium contrast is injected directly into the patient’s vein so that the blood vessels can be identified on the films. Researchers and medical professionals do not know the cause of NSF and currently there is no cure. Patients who are preparing to undergo an MRI should be screened for kidney problems before receiving one of the five imaging agents. There have been no reports of NFS in patients with normal kidney functioning or in those with mild-to-moderate kidney insufficiency.
Manufacturers of the gadolinium agents are:
Bayer Schering Pharma in Berlin, Germany – makers of Magnevist
GE Healthcare in Chalfont St. Giles, U.K. – makers of Omniscan
Mallinckrodt, Inc., in Hazelwood, Missouri – makers of OptiMARK
Bracco Diagnostics, Inc. in Princeton, New Jersey – makers of ProHance and Multihance