New warnings are in store for three imaging drugs. The FDA says it's requiring Bayer, Covidien and GE Healthcare to change the labels of their gadolinium-based contrast agents to highlight the risk of a potentially fatal skin condition when the drugs are given to kidney patients.
The new warnings for Bayer's Magnevist, GE's Omniscan, and Covidien's Optimark will advise against their use in patients with acute kidney injury or chronic severe kidney disease, the FDA said in a statement. Other GBCA drugs will get cautionary language advising that patients be screened for kidney dysfunction before the agents are used.
The agency said that, after reviewing the safety of the GBCA class, it found that Magnevist, Omniscan and Optimark carry a greater risk of nephrogenic systemic fibrosis in kidney patients than the rest of the class did. NSF causes excess fibrous tissue to form in skin, joints, eyes and internal organs, the agency says.
According to the Wall Street Journal, Covidien has already said it would voluntarily change Optimark's label to advise against its use in patients with kidney disease. GE Healthcare tells the newspaper that it would update Omniscan's labeling as FDA requested, while Bayer says it will respond to FDA within 30 days, as required.