Linear gadolinium contrast agents regulatory update

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended to suspend marketing authorizations of 4 linear gadolinium contrast agents due to evidence that the products deposit small amounts of gadolinium in the brain after MRI body scans but “show no signs of harm.” The agents are gadobenic acid, gadodiamide, gadopentetic acid and Optimark gadoversetamide from Guerbet S.A. (Euronext:GBT, Villepinte, France). PRAC recommended the linear agent gadoxetic acid remain on the market, but at a low dose for liver scans because it “meets an important diagnostic need in patients with few alternatives.” It also recommended a formulation of gadopentetic acid that is administered into joints due to its very low concentrations...