Gadolinium Contrast Agent Retention In Brain May Require Label Warning
Executive Summary
US FDA advisory committee to consider whether regulatory actions such as a labeling change are needed and what studies could be done to investigate potential adverse events associated with gadolinium retention in the brain and other body organs.
You may also be interested in...
GBCA Sponsors Must Conduct Human, Animal Studies To Assess Safety
US FDA is requiring additional safety measures related to GBCAs, but holds that there is no direct relationship established between gadolinium retention and kidney function.
Warning Label For Gadolinium Contrast Agents Gets US FDA Panel Backing
Advisory committee agrees that risks of gadolinium retention in the brain and other organs need further study; actor Chuck Norris' wife was among several patients who testified of devastating medical problems following administration of agents.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.