Covidien supports FDA labeling changes for gadolinium-based contrast agents

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced it supports the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, severe kidney disease.

“We contraindicated Optimark in patients with severe renal impairment nearly a year ago. Today's FDA action validates our decision and reinforces the agency's efforts to ensure patient safety and the safe use of all gadolinium contrast agents.”

In November 2009, Covidien's Mallinckrodt business voluntarily contraindicated the use of its Optimark™ (gadoversetamide injection) in MRI procedures involving the same small group of patients with severe renal impairment. The Company added this contraindication to help ensure Optimark is reserved for use in the appropriate patient population - more than 99 percent of patients. Mallinckrodt's previous label change is largely consistent with the new FDA requirements.

"Covidien is pleased the FDA has taken this important step in clarifying the appropriate use of the class of gadolinium agents," said Herbert Neuman, M.D., Chief Medical Officer, Pharmaceuticals, Covidien. "We contraindicated Optimark in patients with severe renal impairment nearly a year ago. Today's FDA action validates our decision and reinforces the agency's efforts to ensure patient safety and the safe use of all gadolinium contrast agents."