Safety questions have begun to swirl around Johnson & Johnson's congestive heart failure drug Natrecor after an article appeared in the journal Circulation yesterday stating the drug had reduced kidney function in patients.
The article concluded that Natrecor caused a 40 to 50 percent greater risk of reduced kidney function when compared with more conventional therapies for heart patients.
An accompanying editorial in Circulation questioned why the FDA failed to follow up on concerns about Natrecor's impact on kidneys and suggested the drug should have received stronger labeling upon its 2001 approval.
According to an article in today's New York Times, Cleveland Clinic cardiologist Steven Nissen has had concerns about the drug's safety ever since he cast the only vote against it while serving on an FDA advisory panel. Nissen said his concerns were based on data showing excessive renal problems.
J&J defended the product yesterday and criticized the analysis, conducted by three cardiologists, saying they had relied on data from patients that received higher doses than are now recommended.
"The doses described in the manuscript are up to three times the recommended dose," Darlene Horton, senior vice president for clinical research for Scios, the J&J unit that makes the product.
Natrecor became part of J&J's portfolio in 2003 when it acquired the biotech Scios in a $2.4 billion deal.
The drug has grown quickly with more than 600,000 patients treated since the drug's approval. Sales of Natrecor remain under $500 million but are growing.