Some use of drug Covidien may up leukemia risk
WASHINGTON (Reuters) - Covidien Ltd has warned doctors its injectable drug, Phosphocol P 32, may increase the risk for leukemia when used to treat conditions not approved by U.S. regulators, the Food and Drug Administration said on Thursday.
Phosphocol P 32, made by its Mallinckrodt Inc unit, is approved to treat fluid leaking in the lungs or abdominal cavity caused by spreading diseases such as cancer or infection.
But two children, aged 9 and 14, with the genetic disorder hemophilia, developed acute lymphocytic leukemia about 10 months after receiving Phosphocol injections, the company said in an August 29 letter to physicians. The drug is not approved for bleeding for such disorders.
Post-marketing reports to the FDA also showed patients experienced radiation injury to the small bowel, bladder and part of the large intestine known as the cecum following administration of the drug, the agency said.
Shares of the Hamilton, Bermuda-based healthcare company fell as low as $47.52 before recovering to close up 68 cents at $55.22 on the New York Stock Exchange on Thursday.
Covidien, formerly known as Tyco Healthcare, separated from its parent Tyco International Ltd in 2007.
Information warning patients and doctors about the two issues has been added to the product's label, according to the letter, which was posted on the FDA's website here#Phosphocol
"We strongly encourage medical professionals and their patients to follow the guidelines outlined in the prescribing information," Covidien said in a statement.
(Reporting by Susan Heavey; Editing by Steve Orlofsky, Andre Grenon, Richard Chang)
