Covidien to modify Optimark labeling

Healthcare technology firm Covidien said it will voluntarily contraindicate the use of its Optimark contrast agent in MRI procedures involving patients with severe renal impairment.

Covidien said it was making the change due to concerns over the relationship between gadolinium-based contrast agents and nephrogenic systemic fibrosis (NSF). The company said that while gadolinium contrast is safe for more than 99% of the population, there could be a risk of NSF for 0.5% of patients with severe renal impairment.

"Although the label already advises caution when using [gadolinium contrast] 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," said Dr. Herbert Neuman, vice president of medical affairs and chief medical officer for pharmaceuticals at Covidien.

The revised label revised label contraindicates the gadolinium-based contrast agent's use in patients with acute or chronic severe renal insufficiency (glomerular filtration rate of less than 30 mL/min/1.73 m2) or acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplant period, according to the St. Louis-based firm.

Covidien said it has submitted the label change to the U.S. Food and Drug Administration (FDA). The new label is effective immediately in the U.S., according to the company. Covidien said it's also changing Optimark's label in all other countries where it is approved for sale, in accordance with local regulatory requirements.

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