Sept. 8, 2017
The FDA Should Ban, Restrict Certain Contrast Agents Used in MRI Scans, Public Citizen Tells FDA Advisory Committee
The European Medicines Agency Has Recommended Limiting Use of the Agents
WASHINGTON, D.C. – The U.S. Food and Drug Administration’s (FDA’s) Medical Imaging Drugs Advisory Committee should advise the agency to withdraw approval for the use of certain “linear” gadolinium-based contrast agents used in magnetic resonance imaging (MRI) and restrict the use of others, Public Citizen said in testimony today. The European Medicines Agency (EMA) made the move in July.
Contrast agents are used in many MRIs to better visualize human tissues. There are two types of such agents: linear and macrocyclic. The EMA called for limits on linear agents based on the concern that they remain in the brain for months or even years after an MRI and could cause long-term harm. Safer, just-as-effective macrocyclic agents don’t remain in the body for such long periods of time.
The FDA estimates that at least 1.7 million U.S. patients received a linear gadolinium-based contrast agent and an equal number received a macrocyclic product during an MRI in 2016.
“Today’s advisory committee highlights yet again how far the FDA has fallen behind the EMA in protecting the public’s health,” said Dr. Sammy Almashat, health researcher with Public Citizen’s Health Research Group. “Earlier this year, the EMA moved to ban and restrict linear gadolinium-based contrast agents, but the FDA has failed to do the same, despite the fact that these contrast agents provide no unique advantages over potentially safer macrocylic agents. The FDA should immediately adopt the EMA’s bans and restrictions on linear gadolinium-based contrast products.”