Contrast agent manufacturer Guerbet has issued a press release expressing its support for the decision by a European Union regulatory body to recommend that four gadolinium-based contrast agents (GBCAs) for MRI scans be pulled off the market due to concerns about gadolinium remaining in the body years after scans occur.
Guerbet's Optimark (gadoversetamide) agent is one of four linear gadolinium-based contrast agents targeted by the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), which had been reviewing the safety of GBCAs. The committee specified that linear agents have "a structure more likely to release gadolinium."
But Guerbet also markets other MRI contrast agents not affected by the recommendation, including Dotarem and Artirem (gadoteric acid). These products are macrocyclic gadolinium-based contrast agents, a class of agents the PRAC ruling specifies has a "much lower propensity to release gadolinium."
Guerbet stated it does not intend a re-examination of the PRAC recommendations.
"Guerbet is strongly committed to providing healthcare professionals with a comprehensive range of effective and safe contrast media in order to improve diagnosis, prognosis, and quality of life for patients," the firm stated.
