Mortality Risks Prompt J&J to Consider Revisions to Natrecor Labeling
Johnson & Johnson's heart-failure medication Natrecor might undergo labeling revisions in the near future to ensure the drug's risks are adequately conveyed to patients, according to a company official.
Natrecor (nesiritide) made national headlines following the release of a Journal of the American Medical Association (JAMA) article that indicated the popular drug was associated with an 80 percent increase in the risk of mortality one month after treatment, compared to conventional therapies, such as vasodilators and diuretics.
Based on a meta-analysis of three previously conducted clinical trials involving a total of 862 patients, the JAMA article was authored by the same researchers who published a study in Circulation last month suggesting Natrecor is associated with a higher risk of kidney problems.
J&J subsidiary Scios, which developed Natrecor, is currently in discussions with the FDA about updating the drug's labeling, J&J Vice President of Investor Relations Helen Short said during a conference call to discuss the company's first-quarter earnings.