FDA Gadolinium Warning

(Oct. 15, 2018)  The FDA issued a warning about gadolinium-based contrast agents in December 2017.  The agency’s Drug Safety Communication concerned gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) for diagnostics.  The FDA alerted health care professionals and patients about the dangers of gadolinium retention.   The FDA announced that a new class warning would be required for all GBCAs concerning gadolinium remaining in the body for months or years  following the drug’s injection for an MRI.

Related:  Gadolinium – MRI Dye Lawsuit

FDA Calls for Gado Dye Safety Tests

FDA also announced that GBCA makers must conduct human and animal studies to further assess the safety of gadolinium contrast agents. The agency is also requiring a patient medication guide be given prior to a patient’s receiving any GBCA.  The FDA says gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the agency “has  concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.”

All People at Risk from Gadolinium

ScienceDaily writes:  “Previously gadolinium was thought to accumulate only in patients with impaired kidney function. New evidence now shows that all patients are at risk. The authors call for urgent retrospective and prospective studies to assess the clinical effects on patients who have been exposed to gadolinium-based contrast during MRI scans.”  See:

Gadolinium Dangers can outweigh Benefits

Despite the FDA’s pronouncement that gadolinium benefits outweigh risks, one might be wise to consider Science Daily’s pronouncement as well as the example of the actor Chuck Norris’ wife.  The FDA warning over gadolinium and nephrogenic systemic fibrosis (NSF) states that only those with diagnosed kidney problems should avoid gadolinium-based contrast agents.  Mr. Norris’ wife had no known kidney problems when she was given GBCA before several MRIs. The couple have charged in several lawsuits against the makers of GBCAs that gadolinium caused Mrs. Norris grievous personal injuries.  And the Norris family is not alone in believing that GBCAs can cause undue harm.

Gadolinium deposition disease is real for many people who were injected with gadolinium prior to an MRI despite their having not been diagnosed with kidney problems beforehand.  Many forums can be found on the web with anecdotal reports from people who say they were injured by gadolinium dye.

Symptoms of gadolinium deposition disease — GDD — can start from within a few minutes to one month after administration of a gadolinium-based contrast agent (GBCA).

Gadolinium Deposition Disease (GDD) Symptoms:

  1. Intense burning of the skin and skin substrate may be felt overall in the entire body, though it may be localized to the trunk area or the distal extremities.
  2. Intense boring pain in bones or joints can arise early after GBCA exposure and affect any bones or joints. Joint pain may be peripheral and also affect large joints such as the knee or hip.  Any bones may feel some severe point pain, but rib pain is distinctive for GDD.
  3. Brain fog or mental confusion can also arise early after GBCA exposure.  Brain fog is also a prominent feature of lead toxicity, another heavy metal malady.
  4. Muscle vibrations (muscle fasciculations) and skin pins and needles/tingling may represent part of the same process that is causing brain fog. Muscle vibrations/twitching and pins and needles skin sensations generally reflect nerve disease or neuropathy.
  5. Head pain or headache, of variable degree, are a very common occurrence.  GDD sufferers describe it as a head pain unlike any head-ache they’ve ever experienced.  Some describe it as a burning pain or an extreme tightness  — like feeling a tight bathing cap on the head.
  6. Distal arm and leg skin/skin substrate thickening, discoloration, pain can arise in the subacute stage at 2 + weeks after GBCA exposure.  This can be similar to the principal features of NSF, but generally less severe. says, “This symptom complex should be expected.”

Gadolinium Lawsuit

Maybe those symptoms should be expected for gadolinium deposition disease, but the makers of GBCA owe a duty to people to warn them of the real dangers of gadolinium contrast dye.  Our law firm is handling gadolinium lawsuits for people adversely affected by gadolinium dye.  Contact us for a free legal consultation if you or a loved one was injured as a result of being injected with gadolinium prior to an MRI.  You may be entitled to significant compensation for any gadolinium-related injuries.