J&J changes heart drug label to show mortality risk
Key points
- Johnson & Johnson on Monday said it had revised the label of its Natrecor (nesiritide) to indicate it increased the risk of death within 30 days after patients were treated with it for heart failure, compared with standard treatments.
- The lengthy new section on "Effect on Mortality" in the package insert label says 5.3 percent of patients taking Natrecor in seven studies died, compared with 4.3 percent of those taking other medicines.
- Although the collective data from the studies reflects a 23-percent higher death rate for those taking Natrecor, J&J spokesman Doug Arbesfeld said the number of patients in the studies was too small to produce conclusive results of death risk.
Johnson & Johnson on Monday said it had revised the label of its Natrecor (nesiritide) to indicate it increased the risk of death within 30 days after patients were treated with it for heart failure, compared with standard treatments.
The lengthy new section on "Effect on Mortality" in the package insert label says 5.3 percent of patients taking Natrecor in seven studies died, compared with 4.3 percent of those taking other medicines.
Although the collective data from the studies reflects a 23-percent higher death rate for those taking Natrecor, J&J spokesman Doug Arbesfeld said the number of patients in the studies was too small to produce conclusive results of death risk.
Written and revised by
Gerald Hurowitz, M.D.
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