Label Changes Announced By FDA In December 2017 Finally Approved For Magnevist, Omniscan, And Other GBCAs In April 2018
Gadolinium based contrast agents (GBCAs) are substances that are injected into patients during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) in order to produce clearer radiology images.
Over the past couple of years drug regulators around the world have started to pay attention to so-called "side effect" of certain GBCAs called Gadolinium Deposition Disease (GDD), which is a form of gadolinium toxicity and sometimes called, instead, Gadolinium Storage Condition.
However, as seen from the following excerpt from our December 2017 article "Gadolinium-Containing Contrast Agents Omniscan And Magnevist Being Recalled In The United Kingdom In February 2018", the actions taken by the FDA are different from what is being done by some other regulators:
In comparison, at the present time FDA is only requiring that there be certain changes made to the Prescribing Information, or drug label, of all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) in the US. To be clear, none of these products will be recalled from the market here.
On December 19, 2017 this document was issued, "FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings".
The gadolinium contrast agent label changes announced in December 2017, however, were not rolled-out until several months later. For example, the FDA waited until April 2018 to finally approved the new drug label for Omniscan.
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From the FULL PRESCRIBING INFORMATION Revised: 04/2018 document for Omniscan (accessed 5/16/18) we get the "class warnings" label change mandated by the FDA:
5.4 Gadolinium Retention
Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)].
It is important to understand that symptoms of gadolinium-related medical conditions can first appear anywhere from just a few hours until several weeks after the MRI or MRA procedure when a GBCA dye was administered by injection.
Some of the more common symptoms reported by patients are:
- Severe pain in the bones, joints, arms, and legs
- Sensation of sharp pins and needles, cutting, or burning
- Thickening of soft-tissue, tendons, and ligaments
- Tightness in the hands and feet
- Nausea / vomiting
- Cognitive impairment
- Clouded mentation (“brain fog”)
- Persistent headache
Our law firm is investigating possible products liability lawsuits against the pharmaceutical companies responsible for the gadolinium-based contrast agents, or contrast dyes, which might cause any of these symptoms.
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