FDA Warnings
Since 2006, the United States Food and Drug Administration (FDA) has released multiple warnings for Gadolinium-based contrast agents that are used for MRI scans. These warnings focus on the link between Gadolinium and Nephrogenic Systemic Fibrosis (NSF), a currently incurable illness that can be fatal. While this information has been available for a few years, many patients were not made aware of the risk of Gadolinium before having an MRI performed.
If you or someone you love has suffered negative effects from a Gadolinium-based contrast agent, you should speak with a Gadolinium side effect lawyer about your legal options. Contact the Gadolinium attorneys of Williams Kherkher today at 800-761-3187.
Prior FDA Alerts
The first FDA alert for MRI contrast agents containing Gadolinium was released in June 2006. This was an initial warning to notify patients and healthcare professionals that the FDA had received reports of 25 different cases in which a patient given a contrast agent developed NSF. All of these patients had suffered from kidney failure. Later in 2006 and 2007, the FDA released a more conclusive warning, stating that gadolinium-based contrast agents had been linked to an increased risk of NSF in patients with kidney problems. This led the FDA to require a black box warning on all contrast agents containing Gadolinium – the highest level of warning that the FDA can assign.
Black Box Warning
The black box warning states that there is a direct connection between Gadolinium-based contrast agents and the onset of NSF in patients with renal or kidney insufficiency. The warning recommends that doctors avoid using these agents in patients with kidney problems unless there is no alternative. They are also instructed to investigate a patient's medical history prior to administering a contrast agent to check for past kidney problems. The black box warning also lists the potential effects of NSF, which include fibrosis of the skin or organs.
If you have developed NSF as a result of exposure to gadolinium in an MRI contrast agent, your physician or the contrast agent manufacturer may be liable for your injuries. The onset of NSF can result in costly medical bills, hospital stays, lost wages from time off of work, emotional distress, and pain and suffering.
Contact Us
Unsafe or careless administration of a Gadolinium-based contrast agent can lead to a debilitating or even fatal case of Nephrogenic Systemic Fibrosis. For sound legal advice and assistance with initiating a lawsuit for compensation for your injuries and damages, contact the Gadolinium attorneys of Williams Kherkher today at 800-761-3187.