Drugs
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Information on Gadolinium-Based Contrast Agents
Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).
To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program using the information at the bottom of the page.
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Related Information
FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction
9/9/2010; updated 12/23/2010FDA: New warnings required on use of gadolinium-based contrast agents
FDA news release (9/9/2010)FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
5/23/2007Information for Healthcare Professionals: Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance)
FDA Alert [6/2006, updated 12/2006 and 5/23/2007]Questions and Answers on Gadolinium-Based Contrast Agents Public Health Advisory: Update on Magnetic Resonance Imaging (MRI) Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy
12/22/2006- Questions and Answers on Gadolinium-Containing Contrast Agents, 12/22/2006
Information for Healthcare Professionals: Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging Scans (marketed as Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance) 12/2006
12/22/2006Public Health Advisory - Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI)
6/8/2006- Questions and Answers on Gadolinium-Containing Contrast Agents, 6/8/2006
Information for Healthcare Professionals: Gadolinium-Containing Contrast Agents for Magnetic Resonance Imaging (MRI) (marketed as Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance)
6/8/2006
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Regulatory History and Labeling from Drugs@FDA
Gadolinium-Based Contrast Agents:
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Contact FDA
1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
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