Magnevist
How the FDA Protects Against Side Effects of Gadolinium
Since the discovery of the link between nephrogenic systemic fibrosis and gadolinium based contrast agents, the FDA have investigated the issue ever since, as well as impose regulations of manufactured contrast dyes to follow to reduce gadolinium side effects as much as possible.
The FDA has mandated that all manufacturers add a boxed warning and a new “Warnings” label to describe the risks of use. Currently, there are 5 gadolinium agents that are approved by the FDA:
- Magnevist
- MultiHance
- Omniscan
- OptiMARK
- ProHance
Contrast agents can be used for MRI and MRA scans. MRI machines (magnetic resonance imaging) are used for getting detailed images of the organs and soft tissue in the body. An MRA (magnetic resonance angiography) scan is a specialized type of MRI, which is designed to capture blood vessels and arteries instead. They are mostly used to detect diseases caused by affected blood vessels, such as aneurysms and atherosclerosis disease.
When it comes to FDA regulations, the two types of scans are completely different. The five contrast agents listed above are only approved by the FDA for MRI scans. They are not approved for MRA scans. In fact, there are NO FDA APPROVED CONTRAST AGENTS FOR MAGNETIC RESONANCE ANGIOGRAPHIES. This is important to note, as there are doctors who will still use gadolinium based contrast agents for MRAs because it improves the quality of the results.
There exist other types of contrast dyes that do not contain gadolinium. There are two that are approved by the FDA – Feridex I.V., which is iron based, and Teslascan, which is manganese based. Being as how these two are only allowed for detecting lesions of the liver, they are not viable alternatives. Only the list above is for general MRI scans, and therefore, the possibility of gadolinium side effects still exists.
To learn more about the specific regulations and guidelines imposed by the FDA regarding gadolinium based contrast agents, check out the FDA website regarding MRI contrast agents.
