Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it will voluntarily contraindicate the use of its Optimark™ gadoversetamide injection, a gadolinium-based contrast agent (GBCA), in magnetic resonance imaging (MRI) procedures involving patients with severe renal impairment. The Company is modifying the product’s label to reflect a contraindication for this small patient population, which constitutes less than 0.5 percent of the U.S. population.
Mallinckrodt Inc., a Covidien company, has submitted this label change to the U.S. Food and Drug Administration (FDA) and is implementing the new label in the U.S. effective immediately. 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.
The Company is implementing this label change in all other countries where Optimark contrast agent has been approved for sale, in accordance with local regulatory requirements. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of this product.
GBCAs are important tools to aid physicians seeking to diagnose and treat patients. In 2008, more than 9.5 million patients in the U.S. were given GBCAs to help improve the diagnostic quality of MRI scans.
When used as directed in appropriately-screened patients, GBCAs have a favorable safety profile, with the majority of any adverse reactions in this class being mild and usually transitory. A possible relationship, however, has been asserted between the use of GBCAs and nephrogenic systemic fibrosis (NSF) among patients with severe renal impairment. This subset of patients can be easily identified by obtaining patient history and/or laboratory tests.