It is undoubtedly one of the miracles of modern medical technology. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) are minimally invasive medical tests that help physicians diagnose and treat medical conditions.
But about four years ago some concern began to arise about the use of so-called contrast agents that are injected into the body to assist in the development of MRI and MRA images. Now, the FDA is increasingly concerned that certain contrast agents may pose a risk of a fatal skin disease.
In fact, the FDA recently announced that it is convening a team of outside experts in December to review a link between certain gadolinium-based contrast agents and a rare skin disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NSD).
NSF/NSD is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. NSF is characterized by areas of tight and rigid skin that make it difficult to bend joints. It may also result in fibrosis or scarring of body organs resulting in the inability of body organs to work properly and can lead to death.
Other signs of NSF/NSD also include:
• Burning
• Itching
• Swelling
• Hardening and tightening of the skin
• Red or dark patches on the skin
• Yellow spots on the whites of the eyes
• Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet
• Pain deep in the hip bones or ribs
• Muscle weakness
The FDA has previously issued a variety of health warnings about these contrast agents, particularly for patients with severe kidney problems, but last week it issued the latest results of a review that found that gadolinium-based contrast agents may increase the risk of NSF/NSD.
Specifically, a staff review found the highest risk of the skin disease was associated with GE Healthcare's Omniscan, Bayer AG's Magnevist, and Covidien's Optimark.
In 2006 and 2007, the FDA issued a series of communications pertaining to the risks for NSF/NSD in association with gadolinium-based contrast agents. In 2007, following FDA requests, manufacturers of the agents revised their labels to include a boxed warning and other information intended to lessen the risk for NSF/NSD. Part of the reason for the outside review is to determine whether that labeling is still sufficient in light of recent findings.
In November, Covidien told the FDA it would voluntarily relabel Optimark to contraindicate its use in MRI procedures with patients with severe renal impairment.
There are currently five gadolinium-based contrast agents are approved by the FDA for use during an MRI. The trade names for these products are:
Omniscan
OptiMARK
Magnevist
ProHance
MultiHance
If you or someone you know has experienced side effects related to one of these drugs, you may have legal rights. Please visit our website to find out more.