OptiMARK (gadoversetamide), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).
What is the problem with OptiMARK?
On May 23, 2007, the U.S. Food & Drug Administration requested the manufacturers of OptiMARK (Mallinckrodt, Inc.) of gadolinium-based contrast agents to add a new boxed warning on the product labeling because of reports linking the agents to the life-threatening skin disorders, Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy.
“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, 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.”
What is Nephrogenic Systemic Fibrosis?
NSF, also known as NFD is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a short period of days or could take weeks to fully develop. NSF can also lead to death.
Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.
Signs of Nephrogenic Systemic Fibrosis
- 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