Gadolinium Contrast Agent – A Dangerous Drug Under Investigation

Many of us who have handled serious personal injury cases, including those involving brain injury have seen MRI’s performed using various contrast agents for years. One of those agents does not appear to be as safe as once thought. Gadolinium, or gadodiamide, is a contrast agent which allows an MRI to define normal tissue from abnormal tissue in the brain and body. The FDA declared Gadolinium safe for use in contrast MRI’s in 1988.
In June 2006, the FDA first notified health care professionals and the general public about the risks of a potentially fatal disease known as nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium. Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.
More recently, on May 23, 2007, the U.S. Food and Drug Administration (FDA) asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).
The requested warning states 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). In addition, it states 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.
People need to be aware of the potential dangers associated with this contrast agent and the contraindications for its use to avoid catastrophic consequences.