Skip to navigation Skip to content

News

Share

FDA Issues Safety Communication and Safety Measures Related to a Commonly Used MRI Contrast Agent: UPDATED

January 2, 2018

originally published September 2015

The U.S. Food and Drug Administration (FDA) has updated a Safety Communication about gadolinium-based contrast agents (GBCAs) which are frequently used to identify new disease activity in MRI scans, including those of people with MS.

UPDATE: The FDA is requiring a new class warning for GBCAs, and other safety measures including a new medical guide with new information for patients receiving gadolinium-based contrast agents. The agency is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents. The FDA also urges healthcare professionals to consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium retention, and provides a table that defines retention characteristics in the updated Safety Communication.

Research suggests that small amounts of GBCAs may be deposited in certain areas of the brain in some people who have received multiple doses of GBCAs. These deposits were identified years after the administration of the contrast agent, indicating that the contrast agent was not completely eliminated from the body.

While there is currently no indication that these deposits are harmful, the FDA has advised healthcare providers and patients against unnecessary use of gadolinium for routine MRI scans.

In 2016, the Society convened a group of researchers, MS healthcare providers, radiologists, people with MS and other stakeholders to discuss the research needs regarding the initial GBCA safety communication and to develop recommendations so that people with MS and healthcare providers will have better information and guidance.   

In 2017, The Consortium of MS Centers convened a group of experts, and included representatives from the National MS Society, to review and revise their MRI Guidelines. The recommendation from the Consortium is for judicious use of gadolinium with the understanding that it remains important for diagnosis and ongoing monitoring of MS in certain situations, however, for routine ongoing monitoring gadolinium may not be needed.

The National MS Society recommends that people with MS and care partners should talk to their healthcare provider if they have questions about the use of gadolinium with MRIs.

Additional Details: Magnetic resonance imaging (MRI) scans are commonly used in MS both to aid diagnosis and also to monitor disease activity and the effectiveness of therapies. Gadolinium is a metal ion (electrically charged molecule) that is infused in the vein during certain MRI procedures. There are numerous gadolinium contrast agents and collectively they are known as GBCAs. GBCAs enable better imaging of active inflammation in brain scans of people with MS.  More research is needed to establish if some GBCAs are more prone to cause deposits than others.  

The new safety communication about GBCAs was made to alert the community about the research findings and steps being taken by the FDA to better understand any possible health risks associated with the gadolinium deposits. Until more is known about the GBCA deposits, the FDA makes the following recommendations:

For People with MS:
• People with MS and care partners should talk to their healthcare provider if they have questions about the use of GBCAs with MRIs.
• (UPDATE) People should tell their health care professional about all of their medical conditions, including if they are pregnant or might be pregnant; the date of their last MRI with gadolinium and if they have had repeat scans with gadolinium; if they have kidney problems.
• People with MS and care partners are urged to report any perceived side effects related to GBCAs to the FDA MedWatch program.  MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

For Healthcare Professionals:
• To reduce GBCA deposits and accumulation, health care professionals should consider limiting GBCA use to situations where the additional information from the contrast agent is considered medically necessary.
• Healthcare professionals are urged to reassess the need for repeated use of GBCAs in current treatment protocols.
• (UPDATE) Healthcare professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium retention -- a table that defines retention characteristics in the updated Safety Communication.
• (UPDATE) The recommendation from a panel of experts convened by the Consortium of MS Centers is for judicious use of gadolinium with the understanding that it remains important for diagnosis and ongoing monitoring of MS in certain situations, however, for routine ongoing monitoring gadolinium may not be needed. 
• Healthcare providers are urged to report any possible side effects discovered related to GBCAs to the FDA MedWatch program.  MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Further Reading
Read the FDA’s Safety Communication
Read more about the use of MRI in MS

Frequently Asked Questions

Q: Why is MRI important in MS care and research?
A: MRI, or magnetic resonance imaging, is an important tool that provides images of normal and abnormal tissues that are inside of our body. The MRI uses a powerful magnet and a specialized computer to generate the images In MS, MRI is able to detect areas of demyelination and nerve damage in the brain and spinal cord that were caused by the disease. Not all areas of abnormality produce symptoms and the MRI can detect disease activity that is not apparent to the individual or to the health care provider. The images help the health care provider make an accurate diagnosis of MS, and help with monitoring response to disease modifying medications. 

In MS drug research, MRI is an important outcome measurement to determine any effect of the drug on the MS disease process.

Q: Why is gadolinium used during MRI?
A: There are several types of MS lesions, or areas of damage and gadolinium contrast agent shows up brightly in lesions where new inflammation or active areas of disease activity are occurring. This helps healthcare providers and researchers track how active a person’s MS is at that time and whether an individual’s treatment is working or needs changing.

Q: What should I do if my doctor prescribes an MRI?
A: Ask whether your doctor is aware of the FDA’s safety communication about gadolinium and whether using a gadolinium contrast agent is necessary for the purposes of the MRI scan which has been prescribed for you.

Q: What could happen to me if I have had numerous MRIs with gadolinium?
A: Health risks from any retained gadolinium are not known at this time. The FDA is working to understand how and why the gadolinium deposits occur and to identify any safety or health risks.

Q: What are MS advocacy organizations doing to better understand the safety of gadolinium contrast agents?
A: In 2016, the National MS Society convened a group of researchers, MS healthcare providers, radiologists, people with MS and other stakeholders to discuss the research needs regarding the initial GBCA safety communication and to develop recommendations so that people with MS and healthcare providers will have better information and guidance. In 2017, the Consortium of MS Centers convened a group of experts, and included representatives from the National MS Society, to review and revise their MRI Guidelines. The recommendation from the Consortium is for judicious use of gadolinium with the understanding that it remains important for diagnosis and ongoing monitoring of MS in certain situations, however, for routine ongoing monitoring gadolinium may not be needed.

Q:  Are there alternative options to using gadolinium contrast agents to detect new or active areas of disease in MS lesions?
A: Though there are a variety of different gadolinium-based contrast agents, currently there are no substitute options that the medical community can use to effectively detect or track new or active areas of disease.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

Share