Topics and Cases - Gadolinium Contrast Base Agents/NSF
Gadolinium is a substance that serves as a contrasting agent in MRI's and MRA's that allows doctors to more easily see a patient's internal organs and tissue and differentiate it more quickly from the blood vessels. This makes a diagnosis easier and sometimes more accurate. Normally, gadolinium is injected into the patient's circulatory system. In patients with normally-functioning kidneys, the substance is expelled from the body quickly, creating no damage or risks.
However, for those with kidney issues, prolonged exposure to gadolinium can lead to a condition known as Nephrogenic Systemic Fibrosis (NSF), a condition that leads to severely restricted joint movement, possible confinement to a wheelchair and even death.
Facts about Gadolinium/NSF:
- Despite passing FDA examination, several contrast agents used in MRIs have been linked to the development of Nephrogenic Systemic Fibrosis, including Magnevist, Multihance, Omniscan and OptiMARK.
- NSF is a relatively "new" disease, as the first recorded diagnosis occurred in 1997. Generally, NSF is a systemic fibrosing disorder that develops in the setting of renal insufficiency and can affect the skin.
- Symptoms of NSF include thickening of the skin, hardening of the skin, breathing difficulties and muscle weakness.
- There is no known cure and no known overwhelmingly-positive prognosis for this condition at this time. Those who suffer from NSF are generally sentenced to a lifetime of pain and suffering.
- FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006.
- Another FDA warning for gadolinium was issued in December 2006 when it was discovered that 90 kidney disease patients developed NSF after MRIs utilizing gadolinium.
- On May 23, 2007, the FDA requested a box warning for all Gadolinium-based contrast agents (GBCAs). This requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing NSF. In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
- On September 9, 2010, the FDA issued a safety announcement requiring label changes for all GBCAs. The announcement advised doctors to not use three of the GBCA drugs--Magnevist, Omniscan, and Optimark--in patients with AKI or with chronic, severe kidney disease.
Litigation News:
- According to news reports, over a thousand lawsuits have been filed across the nation.
- Nearly 500 of those are pending in Multi-district litigation in the U.S. District Court for the Northern District of Ohio before Judge Dan Aaron Polster.
- The case that was to be the first of the multidistrict litigation’s “bellwether trials” was scheduled to commence January 2011 but the case settled out of court on the eve of the trial.