Johnson & Johnson has added data about deaths to the package insert of its heart-failure treatment Natrecor after studies in two medical journals raised questions about an increased risk of fatal &to=http:// english.pravda.ru/world/20/91/366/10637_korea.html ' target=_blank>kidney problems in those treated with the drug.
The label change, which stops short of a warning, was approved last week by the Food and Drug Administration. It reports that in clinical trials 5.3 percent of the patients treated with Natrecor died, compared with 4.3 percent in control groups. But the new label notes that the data might not be statistically significant because of the small numbers of patients involved.
Natrecor, given intravenously, has been used in more than 600,000 patients in the last four years. The drug's main benefit is decreasing shortness of breath in &to=http:// english.pravda.ru/main/2001/12/01/22650_.html ' target=_blank>heart-failure patients, often the most debilitating symptom of the illness.
Despite its cost, more than $500 a treatment, sometimes more than once a week, it is growing in popularity, with many financial analysts expecting it to reach blockbuster status. Some analysts have said it is expected to reach more than $600 million in sales this year, double last year's volume, publishes the New York Times.
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.