An accompanying editorial in the journal, published by the American Heart Association, questioned why the Food and Drug Administration had failed to follow up on concerns about Natrecor's impact on the kidneys and suggested that the drug should have received stronger labeling when it was approved in 2001.
A cardiologist at the Cleveland Clinic said he had had concerns about the drug's safety since he cast the only vote against it while serving on an F.D.A. advisory panel. The cardiologist, Dr. Steven Nissen, said his concerns were based on data showing excessive renal problems.
The analysis, by Dr. Jonathan D. Sackner-Bernstein and Dr. Hal A. Skopicki of North Shore University Hospital in Manhasset, N.Y., and Dr. Keith D. Aaronson of the University of Michigan, was based on a review of clinical trial data submitted to the F.D.A. before the drug's approval.
The article concluded that Natrecor caused a 40 percent to 50 percent greater risk of reduced kidney function when compared with more conventional therapies for heart patients. Reduced renal function is linked to a higher death rate for patients with congestive heart failure.
The F.D.A. said that it could not comment because it had not seen the article.
Courtesy of the NY TImes 3/22/2005
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