Published on June 15, 2005 at 6:31 AM
An independent panel of experts say heart-failure drug Natrecor should be restricted and only used with acutely ill hospitalized patients.
They want drug company Johnson & Johnson to conduct a comprehensive clinical trial, as research indicates that Natrecor may increase the risk of kidney problems and death.
Eugene Braunwald, head of the panel and a Harvard Medical School cardiologist, says the drug is important.
The panel said Natrecor should not be used routinely for heart-failure patients even though there are few similar drugs, until more research is done.
Johnson & Johnson has accepted the panel's recommendations, and are planning a clinical study.
The panel recommend that the drug should be reserved for hospitalized heart-failure patients who have trouble breathing at rest and not outpatients who have breathing problems after mild exertion.
Natrecor is the latest drug to raise safety concerns long after receiving Food & Drug Administration approval.
Merck & Co. and Pfizer Inc. were to forced to pull their respective painkillers, Vioxx and Bextra, off the market after safety concerns arose.