Black Label Warnings
Black label warnings, also known as black box warnings, are prescription drug warnings from the U.S. Food and Drug Administration (FDA). These warnings tell consumers about the potentially serious and life-threatening adverse effects the drug might cause for certain patients. They are the strongest prescription drug warnings issued by the FDA. They are named because of the thick black border that usually surrounds the warning on the prescription box or bottle.
Gadolinium-Based Contrast Agents
In 2007, the FDA issued a black label warning on all gadolinium-based contrast agents, which are used during MRIs. The warning:
- States that gadolinium-containing compounds have been linked to an increased risk of Nephrogenic Systemic Fibrosis, or NSF, in patients with kidney disease, renal problems, or other kidney problems
- Urges doctors to avoid using the agent in patients who have kidney problems unless there exists no other option
- Instructs doctors to take adequate precautions to thoroughly investigate the medical histories of each patient before administering the contrast agent in case the patient has a history of kidney problems
- Lists the potential adverse effects of NSF, including skin and organ fibrosis
If you have been diagnosed with NSF or a similar condition after exposure to a gadolinium-based contrast agent, you should not be forced to suffer from your injuries alone. Doctors who perform MRIs should be aware of the risk of NSF and should completely screen patients before administering a contrast agent. Additionally, each gadolinium-based contrast agent should be clearly labeled with the black box warning, alerting consumers to potential adverse effects of exposure.
Contact Us
To learn more about your legal options, contact the gadolinium attorneys of Williams Kherkher by calling 800-761-3187 today.