A panel of heart specialists issued a warning in June 2005 about the drug Natrecor, which has been associated with higher rates of kidney failure and death.
In addition, a leading cardiovascular expert, the Cleveland Clinic’s Dr. Eric J. Topol, said the congestive heart failure drug does not meet minimal safety standards.
Topol, writing for The New England Journal of Medicine, also said the maker of Natrecor, Johnson & Johnson subsidiary Scios Inc., was improperly promoting the drug for outpatient use - for routine "tune-ups" for heart patients - an indication not listed on its label. Natrecor is intended for patients hospitalized for acutely decompensated congestive heart failure.
"It's a pattern. We saw it with Vioxx ... and we're seeing it now with Natrecor. The twist here is that the aggressive marketing is through the medical community. With other drugs its direct-to-consumer advertising," Topol said in an interview published by Forbes.com, noting that sales of Natrecor are expected to reach $700 million this year.
If you or someone you love suffered severe injury or death due to the use of Natrecor, you may want to contact a Natrecor attorney for a free evaluation of your case.
Topol, chairman of the department of cardiovascular medicine at the prestigious Cleveland Clinic, said Natrecor, which costs about $500 per dose, is being used 10 times more often on an outpatient basis than in hospitals. He said doses are being administered at "infusion centers" started by doctors.
Topol said studies have shown that Natrecor contributes to kidney dysfunction and may cause death. One study showed a threefold incidence of kidney problems among patients using the drug Another found a possible 50 percent increased risk of death after 30 days, while data from another trial found an 81 percent increase in the death rate among Natrecor (nesiritide) users when compared to patients given a placebo.
One study found positives and negatives: While Natrecor improved a measure of cardiac function and reduced breathing problems among patients, those who used the drug had lengthier hospital stays and higher death rates 30 days after using Natrecor.
In September 2006, an analysis of three controlled trials showed nearly double the 30-day mortality in patients with acute decompressed heart failure who used Natrecor even at the recommended doses. The studies included a total of 862 patients.
"In my view, nesiritde has not yet met the minimal criteria for safety and efficacy," said Topol in his commentary article. "Until a trial definitively proves that this drug reduces the risk of death or repeated hospitalization for heart failure, there will be questions about the appropriateness of the drug's use or even commercial availability."
He also criticized the U.S. Food and Drug Administration, which approved Natrecor in 2001, for a "low threshold" for approval. Said Topol, "We need a tune-up of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety."
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