Gadolinium-based contrasting agents were first approved by the Food and Drug Administration in 1988, and between 1988 and 2004 five different brands of the product were introduced into the market – ProHance, OptiMARK, Omniscan, MultiHance, and Magnevist. During clinical trials of the product, patients whose kidney function was compromised or who were on dialysis were not included, because gadolinium is excreted through the kidneys. However, this did not exclude these patients from being administered gadolinium in its commercial use, as a MRI contrasting agent. Patients with renal insufficiency were somewhat likely to develop a disease called nephrogenic systemic fibrosis, which doctors believe that exposure to gadolinium could be a risk factor.
Because of this, many patients are considering gadolinium lawsuits, and many members of the public want to know how these contrasting agents work. Gadolinium is a rare-earth metal that is only magnetic when external magnetic force is applied, and a magnetic resonance imaging, or MRI, machine is a device which uses magnetic force to allow doctors to see inside a patient’s body in some detail, but for the most accurate results a contrasting agent must be used. Gadolinium-based contrasting agents are either swallowed or injected into the patient’s body, depending on the body part being imaged. Although gadolinium-based products are not the only ones used in MRI scanning, they are among the most common.
Gadolinium products were likely approved by the Food and Drug Administration because the only side effects noted in pre-marketing studies were allergic reactions, which ranged from mild to severe and potentially fatal. However, some plaintiffs are claiming that the testing done was incomplete because it did not include those with serious kidney problems, while gadolinium is being used on these patients despite a lack of proper testing. It remains to be seen whether lawsuits against any of the gadolinium distributors will be successful.
