Irish healthcare products maker Covidien Plc (COV), Monday said it is changing the label of Optimark, the contrast agent used in magnetic resonance imaging or MRI scans, to contra-indicate patients with severe renal impairment, effective immediately in the U.S.
Mallinckrodt Inc., a Covidien company, has submitted the label change to the U.S. Food and Drug Administration indicating that Optimark should not be used in patients with acute or chronic severe renal insufficiency, or acute renal insufficiency due to hepato-renal syndrome or those who are in the recovery period from a liver transplant surgery.
According to the company, the contra-indication is for a relatively small population, less than 0.5% of the U.S.
Optimark gadoversetamide injection is a gadolinium-based contrast agent or GBCA used to improve the diagnostic quality of MRI scans. In 2008, more than 9.5 million patients in the U.S. were given GBCAs to help improve the diagnostic quality of MRI scans, noted the company.
Though the GBCA is safe when used as directed, its principle constituent gadolinium has been associated with nephrogenic systemic fibrosis, a serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs, in patients with severe renal failure. The FDA recommended the avoidance of GBCAs in patients with severe renal impairment, in 2007.
"In addition, the FDA will hold a joint Advisory Committees Meeting on December 8 to discuss whether other steps are necessary to ensure the safe use of all GBCAs", added the company.
The company also said that it is implementing this label change in all other countries where Optimark contrast agent has been approved for sale, in accordance with local regulatory requirements.
COV finished trading Monday's regular trading sessions at US$44.82, up US$0.77 or 1.75% on the NYSE.
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