26 avril, 2005 17:23
J&J Adds Mortality Risk to Heart Drug Label
Mon Apr 25, 2005 5:06 PM ET
By Ransdell Pierson
NEW YORK (Reuters) - Johnson & Johnson has revised the label of its Natrecor heart failure medicine to include data that suggest it may increase the risk of death, following two widely publicized medical journal articles that questioned its safety.
J&J did not issue a press release to announce the label change. Instead, a company Web site, Sciosinc.com, published the lengthy label without pointing out which section of it had been added.
"The label was quietly changed by Johnson & Johnson, which apparently doesn't want to attract much attention to the new mortality language," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who in 2001 advised U.S. regulators not to approve Natrecor.
J&J spokesman Doug Arbesfeld said the earlier label carried no language on mortality risks but was revised to include that information following discussions between the company and the U.S. Food and Drug Administration. "It was a mutual decision."
"We are actively informing healthcare professionals who prescribe and administer Natrecor about the updated label," Arbesfeld said.
J&J estimates 600,000 patients have taken Natrecor in the United States since it was approved in 2001. Some analysts believe it could post sales of almost $700 million this year, making it one of J&J's fastest-growing medicines.
The new section on "Effect on Mortality" in the drug's package insert label says 5.3 percent of patients taking Natrecor in seven studies died within 30 days after treatment, compared with 4.3 percent of those who took other medicines -- which include diuretics and intravenous nitroglycerin.
Although the collective data from the studies reflect a 23 percent higher death rate for those taking Natrecor, Arbesfeld said the number of patients in the studies was too small to produce conclusive results of death risk.
Arbesfeld said the label was changed on April 20. That was the day after an article in the Journal of the American Medical Association said pooled data from three studies involving 900 heart failure patients suggested a higher mortality risk of Natrecor.
The article said 7.2 percent of those taking Natrecor died within 30 days of treatment, versus a 4 percent death rate among those taking other treatments. It said a large clinical trial of the drug should now be conducted to eliminate uncertainty about its safety.
Arbesfeld said J&J is not yet planning, however, to conduct such a trial -- which would entail the expense of following thousands of patients. Instead, the company has asked Harvard Medical School cardiologist Eugene Braunwald to review all the company's existing data on Natrecor and to suggest appropriate action.
"A large safety trial of Natrecor is long overdue, but meanwhile doctors should be extremely cautious in choosing this drug," Cleveland Clinic's Nissen said in an interview.
Last month, an article in the journal Circulation found that Natrecor worsened kidney function by as much as 50 percent, based on a review of 1,200 patients. Reduced kidney function is a well-known side effect of Natrecor and it is listed on the label.
Heart failure is a dangerous condition affecting nearly 5 million people in the United States, in which the weakened heart is unable to pump enough blood to the rest of the body.
Natrecor is typically given when a heart failure patient winds up in the hospital with symptoms, including loss of breath and insufficient energy to complete simple tasks.
J&J, which sells a wide array of drugs and medical devices, acquired Natrecor when it bought biotechnology company Scios Inc. for $2.4 billion in 2003.
Shares of Johnson & Johnson closed up 5 cents to $68.54 on the New York Stock Exchange.
