Gadolinium-Based Contrast Agents Get Black-Box Warning: Consumers may be at Risk of Developing Nephrogenic Systemic Fibrosis, the FDA Says

On September, 2010, and after years of investigation, the Food and Drug Administration (FDA) finally concluded that a black-box warning was necessary to inform patients and health care professionals of the risks of using certain Gadolinium-based contrast agents (GBCAs).

More specifically, the FDA said, GBCAs are “inappropriate for use among patients with acute kidney injury or chronic severe kidney disease.” The agency arrived at this conclusion after studies suggested that Gadolinium, an intravenous drug for use with magnetic resonance imaging (MRI), can cause a potentially-fatal condition known as nephrogenic systemic fibrosis (NSF) when administered to patients with kidney disease.

But not all GBCAs are equally risky. Instead, available medical data indicates that Magnevist, Omniscan, and Optimark, are associated with a greater risk of NSF than other GBCAs – the consequences can be devastating, as NSF creates excess fibrous connective tissue in the skin, joints, eyes, and internal organs, leading to an inability to move and even death.

Other symptoms associated with NSF are scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. So dangerous are these symptoms that the FDA has recommended that health care professionals estimate kidney function through laboratory testing before administering GBCAs, and that they avoid the use of GBCAs in patients with kidney disease, among other precautions.

For more information about Gadolinium visit www.fda.gov.

Categories:

Our Firm Is Ready to Fight for You

    • Please enter your name.
    • Please enter your phone number.
      This isn't a valid phone number.
    • This isn't a valid email address.
      Please enter your email address.
    • Please make a selection.
    • Please enter a message.
Put Us On Your Side