Covidien Supports FDA's Patient Safety Efforts for Gadolinium-Based Contrast Agents
ST. LOUIS, Sep 10, 2010 (BUSINESS WIRE) --
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.
In November 2009, Covidien's Mallinckrodt business voluntarily contraindicated the use of its Optimark(TM) (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."
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.3 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.