Gadolinium contrast agents, used to enhance MRI films, can be extremely dangerous for people with kidney problems. Over the past several years it has become apparent that gadolinium contrast dyes are causing a rare and debilitating disease called Nephrogenic Systemic Fibrosis (NSF).
NSF is a relatively new disease, with the first diagnosis of NSF occurring in 1997. Currently, the Center of Disease Control has information about 315 patients with NSF. Sadly, at the present time there are more questions than there are answers about the disease. There are very few effective treatments for NSF, and there is no cure.
What are the initial signs of the rare and serious syndrome NSF/NFD?
Originally thought to be a skin disorder, the diagnosis was termed nephrogenic fibrosing dermopathy (NFD). Gradually, the diagnosis produced wider symptoms and it is now considered a systemic disorder referred to as nephrogenic systemic fibrosis (NSF). Some of the initial signs of NSF/NSD are:
- Development of tight, rigid skin in areas
- Scarring of body organs
- Burning, itching, swelling, hardening and tightening of skin
- Red or dark patches on the skin
- Yellow spots on the whites of eyes
- Stiffness in joints with trouble moving or straightening the arms, hands, legs or feet
- Pain deep in the hip bones or ribs
- Muscle weakness
What is Gadolinium?
Gadolinium (Gd) is a silvery-white, malleable and ductile rare-earth metal. Because of extremely high neutron cross-section of gadolinium, this element is very effective for use with neutron radiography An MRI scan provides clear and detailed pictures of internal organs.
Do I need to worry about developing NSF/NSD when getting an MRI or MRA scan?
NSF/NSD is a rare diagnosis. There have been no reports of NSF in patients with normal kidney function or with those with mild-to-moderate kidney insufficiency. However, if you suspect you may have kidney issues, you should be screened prior to receiving one of these imaging agents. Furthermore, the recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.
There are currently five gadolinium contrast dyes on the market:
- Omniscan by GE Healthcare
- OptiMARK by Mallinckordt/Tyco Healthcare
- Magnevist by Bayer/Schering AG/Berlex
- ProHance by Bracco Diagnostics
- MultiHance by Bracco Diagnostices
A History of NSF/NSD and Gadolinium
1988 – Gadolinium contrast dyes were approved for use in MRI scans and quickly became the preferred contrast agent for use in patients with chronic kidney disease.
1997 – First known diagnosis of NSF
September 2000 – Details of NSF are published in the medical journal Lancet.
May 29, 2006 – Danish Medicines Agency reports 25 cases of NSF/NFD occurring in Denmark and Austria
June 8, 2006 – FDA issues first Public Health Advisory to healthcare professionals and the public warning of the risk of NSF due to Gadolinium. At this time, the FDA received reports of 90 additional patients with moderate to end-stage kidney disease who developed NSF/NSD after they had an MRI or MRA with a gadolinium-based contrast agent. As of June 2006 there are 215 patients known worldwide.
December 22, 2006 – FDA issues a second Public Health Advisory
March 15, 2007 - Dr. Melanie Blank, an FDA kidney specialist issues a report concluding that an "undeniable and strong association" existed between contrast agents containing gadolinium and NSF. Read FDA report here.
May 23, 2007 – The FDA requests that all manufacturers of Gadolinium based contrast agents place a black-box-warning[i] for contrast agents used for MRI imaging, namely that such warning should disclose that “patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF)”
April 2, 2010 - Cook County Circuit Judge Dooling grants an order allowing for punitive damages against GE based on the evidence she reviewed with regards to Robbie Booker v. GE, one of the approximate 500 lawsuits filed by NSF patients against GE. Read the court order here.
September 9, 2010 - The FDA requires a change in the labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF). In the safety alert, the FDA acknowledges that NSF is a rare but serious condition associated with the use of GBCAs in certain patients with kidney dysfunction. Read the FDA Safety Alert here.
[i] A black box warning is the most serious medication warning required by the FDA. A black box warning appears on the label of a prescription medication to alert consumers and healthcare providers about safety concerns, such as serious side effects or life-threatening risks.