UK Pulls Two Gadolinium Contrast Agents From Market
MRI contrast agents, also known as gadolinium contrast media, are used in magnetic resonance imaging scans. When they are injected into the body, they enhance the quality of the scans. This helps identify any diseases or abnormalities in the body.
However, since 2011, there have been published reports about gadolinium being retained in the body. The Food and Drug Administration (FDA) has released safety reports about gadolinium since 2015.
Gadolinium is a toxic chemical that does not leave the body quickly. Therefore, if a person undergoes multiple MRIs in a short period of time, it’s possible for the body to retain excess gadolinium, which can result in serious medical conditions.
A person can experience the effects of gadolinium in just a few days after the injection, or several months later. Gadolinium retention can cause pain in the bones and ribs, burning sensations, joint stiffness, a decrease in mobility, headaches, muscle weakness, swelling, red patches of skin and yellowing of the eyes. It can also lead to kidney problems. There are also concerns that gadolinium can be retained in the brain, causing confusion and other memory issues.
Why Did The UK Remove Gadolinium Contrast Agents From Market?
According to the letter, European studies of MRI data have confirmed the possibility of gadolinium deposition in the brain. The letter recommends the use of macrocyclic agents in place of gadolinium because they come with a lower risk of gadolinium retention due to their stability. This class of agents includes gadobutrol, gadoteric acid and gadoteridol, which are less likely to release gadolinium into the body and cause side effects.
Macrocyclic agents have not yet been restricted. They can be used in their current indications as long as they are used in the lowest doses. They must be used only when unenhanced body scans are not sufficient.
While there is no evidence that gadolinium deposition in the brain has led to adverse neurological effects in patients, data are still very limited. The MHRA decided to err on the side of caution and put the suspensions in place to limit potential risk.
Actions Taken by UK Regulatory Agency
Due to these safety issues, the United Kingdom has pulled two of these contrast agents off the market. In December 2017, the IV formulations of gadodiamide (Omniscan) and gadopentetic acid (iv Magnevist) were discontinued in the UK. The licenses for these two agents were suspended on February 1, 2018. Radiographers were advised to replace these products with alternatives.
This action was taken by the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA sent letters to healthcare providers informing them of the decision to take gadolinium off the market. Any stock remaining after February 1, 2018, was recalled.
What To Do If You Have Been Diagnosed With Gadolinium Toxicity?
Most patients confirm gadolinium toxicity via a 24-hour urine test. While the urine test is not 100% conclusive, the results, in tandem with medical records can often provide the basis for determining whether a patient suffers from Gadolinium Deposition Disease (GDD.)
If you or a loved one have been diagnosed with Gadolinium Toxicity or GDD, contact the Gadolinium Toxicity Attorneys of Nadrich & Cohen now for a free and confidential consultation. Call us today at 1-800-718-4658. We are available to answer any questions that you may have.