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
www.covidien.com to learn more about our business.