Summary

The JAMA study found that patients who took Natrecor were 80 percent more likely to die within a month than patients who took older and more affordable drugs instead. The FDA is not yet certain that Natrecor represents a danger, although FDA representatives say they are watching the debate closely. Scios has asked Harvard Medical School's Dr. Eugene Braunwald to organize a panel of independent heart experts to review the existing data.

Original source:
http://washingtontimes.com/upi-breaking/20050418-055056-3159r.htm

Details

• Washington, DC, Apr. 19 (UPI) -- A team of cardiologists said Tuesday their analysis of data on the medication Natrecor obtained from the manufacturer suggests it could be placing heart-failure patients at an increased risk of death.
• Natrecor -- generic name nesiritide -- is manufactured by Scios Inc. of Fremont, Calif., and is used for the treatment of heart-failure patients with shortness of breath.
• The current study -- based on an analysis of clinical trials conducted by Scios as well as data from the Food and Drug Administration -- found patients treated with Natrecor were 80 percent more likely to die in the month after they received the drug than those who received older and less-expensive drugs, such as nitroglycerin and diuretics.
• The latest study appears in the April 20 issue of the Journal of the American Medical Association.
• Sackner-Bernstein, who also serves as a consultant to the FDA's cardiovascular and renal drugs advisory committee, told United Press International that pooling data together from different studies is not the best way to assess mortality risk, but he added this is the best available evidence and "this is a pretty strong signal" that needs to be investigated.
• "Our full data set which includes the three studies looked at in (JAMA study) does not support the finding of these authors (of the JAMA study)," Mark Wolfe, a spokesman for Scios' parent company Johnson and Johnson, told UPI.
• Wolfe said the drug is "highly effective" for the treatment of heart failure, but added his company takes "any question about the safety of Natrecor seriously."
• For that reason, Scios has asked esteemed cardiologist Dr. Eugene Braunwald, of Harvard Medical School, to head a panel of heart experts who will review the data on the drug -- a move the company announced last week apparently in response to the Circulation article that raised the issue of kidney problems.

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