Covidien Submits Label Change for Optimark(TM) Contrast Agent

November 9, 2009 8:00 AM EST

New Label Contraindicates Product for Use in Patients with Severe Renal Impairment

ST. LOUIS--(BUSINESS WIRE)-- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it will voluntarily contraindicate the use of its Optimark(TM) 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.

"We have concluded that Optimark contrast agent should be reserved for the vast majority of the population - more than 99 percent - where the risk/benefit profile is well established," said Dr. Herbert Neuman, Vice President, Medical Affairs and Chief Medical Officer, Pharmaceuticals, Covidien. "For the small percentage of the U.S. population - less than 0.5 percent - with severe renal impairment, we believe it is prudent to act now, rather than wait for a causal link between GBCAs and NSF to be established. Although the label already advises caution when using GBCAs with these patients, we are voluntarily taking this next step to help ensure this small, at-risk population does not receive administration of a contrast agent that could pose a risk of NSF."

In 2007, the FDA recommended that use of all GBCAs should be avoided in patients with severe renal impairment unless the diagnostic information is essential and only available with a contrast-enhanced MRI procedure, resulting in a boxed warning for each GBCA. 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.

"At Covidien, patient safety is our highest priority," Dr. Neuman said. "The extensive efforts of the FDA, industry, clinician organizations and thought leaders since 2006 have increased awareness of NSF and its apparent relationship to GBCAs in patients with severely impaired renal function. This increased awareness has had a noticeable impact on the practice of medicine and contributed to a significant reduction in the incidence of the disease. We look forward to additional dialog with the FDA and the joint Advisory Committees on this important topic."

About Covidien

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 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Forward-Looking Statements

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates, issues related to our existing material weakness in accounting for income taxes or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.

    Source: Covidien

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