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–September 8, 2006
Johnson & Johnson has ordered a new study on the safety and effectiveness of its heart failure drug Natrecor after scientists said it may raise the risk of potentially fatal kidney problems.
Researchers at the Duke Clinical Research Institute, a division of Duke University Medical Center, will likely begin the study early next year. Dr. Robert M. Califf will be chairman of the new study, which will involve approximately 7,000 patients.
The study will "provide important clinical data about the impact of Natrecor on outcomes that matter - most importantly, symptoms relief, readmission to hospital for heart failure and death," said Califf.
The U.S. Food and Drug Administration approved Natrecor in 2001 for use in the treatement of acute decompensated heart failure, a condition in which the heart suddenly stops pumping efficiently.
In May 2005, Johnson & Johnson heightened the label on the drug, warning of the increased risk of kidney problems and death. Since that time, the drug has raised doubts within the medical community about its safety and efficacy.
Injured by Natrecor? Please contact us today to learn more about recovering compensation for your losses and suffering.