Natrecor's new labeling information for doctors updates mortality risks
WASHINGTON The F-D-A is ordering a drug company to tell doctors about the latest research concerning risk of death from a heart failure drug. Four studies have shown that patients given the drug Natrecor are more likely to die within a month. But three other studies have shown a decreased risk.
The Food and Drug Administration order requires that the information be included in the package insert for doctors.
The revision also adds information on six month death rates that showed virtually no increased risk of death with Natrecor.
The drug is given intravenously. It was approved in 2001 to treat serious breathing problems that often accompany heart failure. Natrecor has been used by more than 600-thousand patients in the United States.
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