News & Press: Patient Safety

FDA Offers Podcast on Gadolinium-Based Contrast Agent Retention; EMA Implements Restrictions

Friday, January 5, 2018  

The Food and Drug Administration (FDA) has released a new Drug Safety Podcast, warning that gadolinium-based contrast agents (GBCAs) are retained in the body and describing new class warnings. Providers will be required to provide a new Patient Medication Guide that every patient will be asked to read before receiving a GBCA. FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.

FDA’s Division of Drug Information Drug Safety Podcast

Additional information:

European Medicines Agency (EMA)
Following a scientific review of gadolinium deposition in the brain and other tissues, the European Medicines Agency (EMA) has implemented restrictions on linear gadolinium agents in body scans. For more information,
read that report.

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