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Gadolinium Warnings

Since 1988, contrasting agents containing gadolinium have been Gadoliniumeffectively used with MRIs to highlight abnormal cell and tissue growths. While gadolinium is still used today to diagnose a number of health conditions, it is not used on certain patients, specifically those with kidney (renal) conditions, as it can cause serious side effects.

Among the range of possible health complications associated with gadolinium, the most serious is Nephrogenic Systemic Fibrosis (NSF). In some cases, NSF will develop in renal failure patients after they have been exposed to gadolinium.

FDA Alerts and Gadolinium Warnings
After initial findings of gadolinium's side effects, the Food and Drug Administration (FDA) issued a series of alerts: the first in June 2006, the second in December 2006 and the last in May 2007. Through these national alerts, the FDA mandated that:

Related Topics:

Dangerous Drug Alert:

    Other Gadolinium News:

  • warnings about NSF appear in "call out" boxes within the full prescribing information for all gadolinium-based contrasting agents (GBCAs)
  • new gadolinium warning labels specifically point out the risk of developing NSF in patients with renal failure, renal insufficiency, cirrhosis or recent liver transplants
  • doctors avoid using gadolinium agents in any of the above listed patients unless vital diagnostic information can't be obtained with any other methods or procedures

In addition to these guidelines, the FDA has also outlined a series of specific topics and issues that doctors should discuss with patients before administering GBCAs.

Gadolinium Facts
Below are important facts regarding gadolinium, its side effects and related warnings:

  • By the time the FDA issued its first gadolinium warnings in 2006, the Danish Health Authority had already identified 25 patients with NSF after gadolinium use.
  • The time it takes patients to develop NSF after gadolinium exposure varies according to individual health and circumstances.
  • Currently, NSF has never developed in patients with normal kidney function nor in patients with mild to moderate renal insufficiency after being exposed to gadolinium agents.
  • To date, nearly 200 patients worldwide have reported developing NSF after gadolinium exposure.

Diagnosed with NSF?
Gadolinium was first linked to NSF in 2000, but it wasn’t until 2006 that the FDA issued its first warning regarding the risks of gadolinium-based MRI dyes. If you or someone you love has been diagnosed with this debilitating condition, contact us today to learn more about your legal options. 



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Gadolinium Quick Facts

Gadolinium Quick Reference Guide
Other Names: 

Gadodiamide

Date Approved:
May 1982

Manufacturer:
GE Healthcare- Omniscan
Bayer Schering- Magnevist
Mallinckrodt- OptiMARK
Bracco Diagnostic- ProHance and Multihance

Status:
Black Box Warning

Approved Uses:
MRI Contrast agent

Off-Label Uses:
MRA Contrast agent

Serious Side Effects:
Allergic reactions
Headache and Nausea
Inflammation or irritation of blood vessels
Nephrogenic Systemic Fibrosis (NSF)
Nephrogenic Fibrosing Dermopathy (NFD)
Restricted movement of joints
Thick and hard skin
Yellow marks in whites of eye

Common Misspellings:
gadalinium
gadalineum
gadolineum
gadulinium
gadoliniom

Related Topics:
Nephrogenic Systematic Fibrosis (NSF)
Nephrogenic Fibrosing Dermopathy (NFD)
Defective Drugs