The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended the suspension of the European marketing authorizations for four linear gadolinium contrast agents (GdCAs) because of the presence of small amounts of gadolinium in the brain. No harm linked to gadolinium in the brain has been reported.
GE Healthcare is exercising its right to request a re-examination of the PRAC recommendations, which do not represent the final decision of the European Authorities on the benefit-risk balance of linear GdCAs. Recommendations would require adoption by the Committee of Medicinal Products for Human Use (CHMP) which, if accepted, would be provided as a formal opinion to the EU Commission. GE Healthcare remains firm in our evidence-based belief that the overall benefit-risk profile of linear agents including Omniscan is positive.
Safety of patients is the most important priority for GE Healthcare, and we will continue to work with authorities at each stage of the process to ensure the safe use of GdCAs. We look forward to further discussions with the EMA on these points:
- While there is clear evidence that all types of GdCAs, both linear and macrocyclic, may result in trace amounts of gadolinium in the brain, there exists no clinical evidence that this leads to an increase in risk or harm to patients.
- Omniscan has an excellent tolerability and low acute adverse event profile as seen in analyses of data from publications related to clinical use of Omniscan. In addition, Omniscan has a specific cardiac indication in several European Member States; removing it would limit clinical choice.
During the PRAC re-examination procedures, GE Healthcare will employ all available pharmacovigilance measures and continue our research program to better understand any potential risks from brain gadolinium. We are committed to ensuring that Omniscan (gadodiamide) will continue to be available as an option for clinicians to use according to its approved Prescribing Information.
Prior to Omniscan administration, please read the Full Important Risk and Safety information and Full Prescribing Information.