-
Drugs
-
Information on Gadolinium-Containing Contrast Agents
| The issue described in this communication has been addressed in product labeling. Please see Drugs@FDA. |
The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).
-
Related Information
- FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
5/23/2007 - Information 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
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
12/22/2006 - Public 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
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
-
-
Gadolinium-Containing Contrast Agents
Labeling and Regulatory History from Drugs@FDA
- Prescribing Information - Gadobenate Dimeglumine (marketed as MultiHance)
- Prescribing Information - Gadodiamide (marketed as Omniscan)
- Prescribing Information - Gadopentetate Dimeglumine (marketed as Magnevist)
- Prescribing Information - Gadoteridol (marketed as ProHance)
- Prescribing Information - Gadoversetamide (marketed as OptiMARK)
-
Contact Us
- 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 20852-9787
-
-
-