As of April 26, 2018, the revised Product Labeling with the Medication Guide for all gadolinium-based contrast agents (GBCAs) were posted on the FDA’s website. The FDA announced on December 15, 2017, that it was requiring GBCA manufacturers to revise product labeling and create a Medication Guide for each GBCA. The purpose of the Medication Guide is to provide patients with information about gadolinium retention in the body so that they can make an informed decision before agreeing to have an MRI with contrast – an MRI with a gadolinium-based contrast agent. Gadolinium (Gd) is a toxic metal and any amount that remains in the brain and other parts of the body has the potential to have a harmful effect. While the linear GBCAs are the least stable, macrocyclic agents have been found to leave residual gadolinium in patients’ bodies as well. The long-term effects of gadolinium deposition are still unknown; however, research is ongoing.
The Medication Guide for each agent mentions “many doses of gadolinium medicines” as a possible risk factor. Gadolinium-based contrast agents are intravenously administered prescribed drugs that can have a toxic effect even after one dose of contrast. Currently, no one knows why some patients become symptomatic after having one or more MRIs with a GBCA, while others do not. However, it appears that everyone retains an unknown amount of gadolinium from each dose of a gadolinium-based contrast agent they receive.
Links to the new Product Labeling for each agent are provided below. The Medication Guide is part of the new product labeling and is included in the PDF.
12/19/2017 – FDA Safety Announcement
Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication – Retained in Body; New Class Warnings https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm
Dotarem – Guerbet LLC
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf?utm_campaign=Medication%20Guides%20April%202018%20%3A%20Copy&utm_medium=email&utm_source=Eloqua&elqTrackId=0a2bb5a1eb2a45d79ac124cff26ceb81&elq=891fe8eaea224e16926b26d5fb831b94&elqaid=3332&elqat=1&elqCampaignId=2521#page=29
Dotarem Medication Guide is on page 14 of the PDF
Eovist – Bayer HealthCare Pharmaceuticals Inc.
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s014lbl.pdf
Eovist Medication Guide is on pages 15 & 16 of PDF.
Gadavist – Bayer HealthCare Pharmaceuticals
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201277s013lbl.pdf
Gadavist Medication Guide is on pages 18 & 19 and 37 & 38 – it looks like the current PDF has two copies of the labeling.
Magnevist – Bayer HealthCare Pharmaceuticals, Inc.
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s063lbl.pdf
Magnevist Medication Guide is on pages 13 & 14 of PDF.
MultiHance – Bracco Diagnostics, Inc.
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf
MultiHance Medication Guide can be found on page 34 of the PDF.
Omniscan – GE Healthcare, Inc.
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf
Omniscan Medication Guide is on page 1 of the PDF.
OptiMark – Liebel-Flarsheim Company LLC
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020975s028lbl.pdf
OptiMark Medication Guide is on pages 13 & 14 of PDF.
ProHance – Bracco Diagnostics, Inc.
2018 Product Labeling – https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf
ProHance Medication Guide is on page 1 of the PDF.