United States Food and Drug Administration (FDA) Warnings

 

FDA warnings to the product labeling for the following contrast agents:

* Gadolinium based contrast agents - The FDA has requested manufacturers of all gadolinium based contrast agents to add new warnings about exposure to gadolinium based contrast agents, which increases the risk for nephrogenic systemic fibrosis in patients with advanced kidney disease. The full text of the warning is available at: http://www.fda.gov/cder/drug/infopage/gcca/default.htm

* Microbubble contrast agents - The FDA has requested that a Boxed Warning and other warnings emphasizing the risk for serious cardiopulmonary reactions be added to the labeling for microbubble contrast agents and that use of these products be contraindicated in patients with unstable cardiopulmonary status, including patients with unstable angina, acute myocardial infarction, respiratory failure, or recent worsening congestive heart failure. The full text of the warning is available at: http://www.fda.gov/cder/drug/InfoSheets/HCP/microbubbleHCP.htm


[HOME]