Gadolinium Based Contrast Agents Now Carry Black Box Warning
May 23, 2007
In May 2007, the FDA ordered all manufacturers of gadolinium based contrast agents to include a black box warning on their product labels. A black box warning is the strongest warning that the FDA requires and means that a particular drug carries a significant risk of serious or even life-threatening side effects. Specifically, the gadolinium black box warning states that patients with kidney problems or renal failure are at risk of developing Nephrogenic Systemic Fibrosis (“NSF”) / Nephrogenic Fibrosing Dermopathy (“NFD”) if injected with gadolinium.
The FDA has announced that it will continue to investigate the connection between NSF / NFD in patients with kidney problems and gadolinium based contrast agents. In the meantime, the FDA has asked all persons with kidney problems who have been diagnosed with NSF / NFD to report their symptoms to the agency.
Nephrogenic Systemic Fibrosis (“NSF”), also known as Nephrogenic Fibrosing Dermopathy (“NFD”), is a debilitating, and sometimes fatal disease that affects people with pre-existing kidney diseases who have undergone MRIs involving gadolinium contrast dyes. Currently, no cure exists for NSF / NFD and no one understands its specific cause. Symptoms of NSF / NFD include high blood pressure and burning, itching, swelling, and hardening of the skin. Additionally, NSF / NFD can cause red or dark patches on the skin, pain deep in the hip bones or ribs, and muscle weakness. In some cases, NSF / NFD can progress to the point of causing severe stiffness in joints, and it can lead to death.
Contrast agents, which are injected via an intravenous line in your hand or arm, are used to make MRI scans easier to evaluate. However, not all MRIs require a contrast agent. Before having an MRI, patients should ask their doctors if a gadolinium based contrast agent will be used. If the answer is yes, patients should have their kidney problems defined and their levels of kidney function evaluated before considering having an MRI exam with gadolinium-based contrast.
If you or a loved one has kidney problems and has been injured by Gadolinium, please contact us today as you may be entitled to compensation for your injuries.