ST. LOUIS—Drug and medical device company Covidien said Nov. 9 that it is changing the label of its imaging agent Optimark to indicate that it is dangerous for use in patients with severe renal impairment.
Optimark gadoversetamide injection is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) procedures.
Mallinckrodt Inc., a Covidien company, has submitted this label change to the U.S. Food and Drug Administration and is immediately implementing the new label in the United States.
The revised label contraindicates the product’s use in patients with acute or chronic severe renal insufficiency (glomerular filtration rate of less than 30 mL/min/1.73m2) or acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplant period.
“We have concluded that Optimark contrast agent should be reserved for the vast majority of the population—more than 99 percent—where the risk/benefit profile is well established,” said Dr. Herbert Neuman, vice president, medical affairs and chief medical officer, pharmaceuticals, Covidien. “For the small percentage of the U.S. population – less than 0.5 percent – with severe renal impairment, we believe it is prudent to act now, rather than wait for a causal link between GBCAs and NSF to be established. Although the label already advises caution when using GBCAs with these patients, we are voluntarily taking this next step to help ensure this small, at-risk population does not receive administration of a contrast agent that could pose a risk of NSF.”
