Covidien adds kidney risk to Optimark label

Covidien says it is changing label of imaging agent to include risk to kidney disease patients

• On 10:46 am EST, Monday November 9, 2009

NEW YORK (AP) -- Drug and medical device maker Covidien PLC said Monday it is changing the label on its imaging agent Optimark to show that the product could be dangerous to patients with severe kidney problems.

Covidien said the new label will indicate that Optimark should not be used in patients who have severe acute or chronic renal insufficiency, in patients who have kidney failure due to cirrhosis of the liver, or in patients who are about to have or are recovering from a liver transplant.

The Irish company said those patients make up less than 0.5 percent of the U.S. population combined.

Covidien said it submitted the label change to the Food and Drug Administration and is implementing it immediately. The changes will be made in all countries where Optimark is approved.

In morning trading, Covidien shares rose 56 cents to $44.61.