A message for our customers about the Pharmacovigilance Risk Assessment Committee recommendation on linear gadolinium agents
On July 7, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended to suspend broad spectrum intravenous use of linear gadolinium agents except for select indication of liver imaging.
The PRAC's recommendation applies to Europe only and is not binding until the PRAC recommendation is reviewed and adopted by the Committee for Products for Medicinal Use (CHMP) and the European Commission.
Multiple other regulatory agencies and organizations have expressed views on this topic which are different to the PRAC regarding suspension or restriction of linear agents. These include the US Food and Drug Administration (FDA), American College of Radiology (ACR) and International Society for Magnetic Resonance in Medicine (ISMRM).
All three organizations communicated that to date, there are no observed short or long term risks associated with Gadolinium in the brain and did not recommend to suspend or restrict the use of linear agents.
We believe that the overall benefit-risk profile of linear agents including Omniscan is positive and should remain as an option for radiologists. Patient safety is our priority and we will continue to work with authorities at each stage of the process to ensure the safe use of GdCAs. In the meantime, we will continue to make Omniscan available as an option for clinicians to use per its approved prescribing information.
NOTE: Prior to Omniscan administration, please read the Full Important Risk and Safety information and Full Prescribing Information. For those outside the USA, please ensure you read your local country Prescribing Information.