Omniscan
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.
News Report About Gadolinium Side Effects
There was a recent news article about a woman who recently settled a lawsuit with GE Healthcare after developing nephrogenic systemic fibrosis because of the side effects of gadolinium. GE Healthcare manufactures the FDA approved gadolinium based contrast agent known as Omniscan.
54 year old Margaret Roxbough of Glasgow, Scotland, went for an MRI exam in September 2006. It was a standard procedure, and she was administered with the Omniscan contrast agent to improve the results of the scan. However, neither she nor the doctor knew that she had kidney disease. Without functional kidneys, the body was not able to expel the traces of gadolinium from her body afterwards, and allowing NSF to develop. Although there was “horrendous pain” the next day, the doctor wrote it off as mild side effects of the MRI scan and said they should go away soon enough.
Margaret Roxbough still experiences excruciating pain. The skin on her legs is completely raw and it is too painful to cover it with any type of clothing.
In 2004, two years prior to her scan, a woman in Denmark had died from the symptoms of nephrogenic systemic fibrosis. In 2006, it had been noted by Henrik Thomas that all the patients diagnosed with NSF at his hospital had one thing in common – they were injected with Omniscan, the contrast dye produced by GE Healthcare.
Subsequently, Ms. Roxbough had sued GE Healthcare, and the lawsuit was recently settled. The FDA now requires a warning label detailing the risks of NSF on Omniscan agents, as well as all FDA regulated gadolinium based contrast agents.
This could have been avoided had it been known she was suffering from renal disease prior to her MRI scan. It is absolutely crucial that if the doctor suggests the use of a contrast dye for an MRI scan that YOU GET TESTED FOR KIDNEY DISEASE BEFORE THE PROCEDURE to avoid all side effects of gadolinium contrast dye. If you do have a documented history of kidney complications, be sure to discuss the severity of the problems and how risky a gadolinium based contrast agent would be to your health.
