Gadolinium Deposition Disease And Neurological Adverse Reactions Associated With The Use Of Gadolinium-Based Contrast Agents
In May 2018 Health Canada announced the results of its second safety review of Magnevist, MultiHance, Omniscan, and Optimark, as well as other radiology contrast agents containing gadolinium.
From "Summary Safety Review - Gadolinium based contrast agents - Assessing the risk of gadolinium build-up in the brain and potential brain and nervous system (neurological) side effects" we get the following points, which are found in the Key Messages section:
- In 2016, Health Canada reviewed the risk of gadolinium build-up in the brain and the unknown potential neurological side effects because some published studies showed that gadolinium may stay in the brain when [gadolinium based contrast agents (GBCAs)] are given repeatedly. Health Canada’s review concluded that the risk of gadolinium build-up in the brain is higher with repeated doses of both types of GBCAs, and with the use of linear GBCAs compared to macrocyclic GBCAs....
- Health Canada carried out a second review in 2017 because new information was emerging, including: a review from the European Medicines Agency; reports from the manufacturers; and scientific publications. Health Canada’s second review concluded that children and pregnant women may be at greater risk of gadolinium build-up in the brain.
In more detail, as set forth in the Safety Review Findings part of that same May 2018 Health Canada document:
- This safety review looked at published and unpublished studies (57 in humans and 12 in animals) and 7 international case reports of gadolinium build-up in the brain linked to the use of GBCAs. The human studies and case reports found evidence of gadolinium build-up in the brain, in most cases this occurred many months after the use of GBCAs. Similar findings were seen in the animal studies.
- Evidence from these studies suggests that the risk of gadolinium build-up in the brain is higher with repeated use of GBCAs and with linear GBCAs. However, gadolinium build-ups were seen with both types of GBCAs.
- The review did not find any neurological side effects linked to gadolinium build-up in the brain based on the information available at the time. However, it is difficult to identify potential effects because they could take some time to appear and some patients may have similar symptoms because of their condition.
- Factors that may increase the risk of gadolinium build-up in the brain following the use of GBCAs are not yet completely understood. However, patients who may need repeated GBCA use and vulnerable populations (e.g. children, pregnant women) may be more at risk of gadolinium build-up in the brain.
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In conclusion, Health Canada -- similar to what the FDA has said here in the US -- stated that it will continue to monitor drug safely information involving GBCAs and, in particular, the link between repeated gadolinium contrast agents administration or injection and the risk of gadolinium build-up in the brain, i.e., Gadolinium Deposition Disease (GDD).
Our law firm is investigating possible products liability lawsuits against the pharmaceutical companies responsible for the linear gadolinium-based contrast agents, or contrast dyes, which are shown below:
Magnevist -- Bayer HealthCare Pharmaceuticals Inc.
Eovist -- Bayer HealthCare Pharmaceuticals Inc.
MultiHance -- Bracco Diagnostics Inc.
Omniscan -- GE Healthcare
OptiMARK -- Liebel-Flarsheim Company LLC
Ablavar -- Lantheus Medical Imaging, Inc.
If we can be of assistance to you or a loved one as regards a possible gadolinium contrast agents case, please do not hesitate to contact us.
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