Word: nissen
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...drugs and dozens of cases of stroke and arrhythmias, but cause and effect are far from certain. Those are small numbers given that 2.5 million kids and 1.5 million adults in the U.S. take the drugs, but some panel members think many cases may go unreported. Cardiologist Steven Nissen, who proposed the warning, is worried about adults on the drugs, 10% of whom are over 50 and may have other risk factors for heart trouble...
...warning warranted? Not at this point, says Dr. Thomas Laughren of the FDA. But the agency will review the risk labels on the drugs and probably launch a formal study of cardiovascular dangers. Over-prescription is another big concern. Nissen notes that 10% of 10-year-old boys are being treated for attention-deficit/hyperactivity disorder...
...meeting took an unexpected turn when cardiologist Steven Nissen of the Cleveland Clinic made a motion for a black box warning. Dr. Nissen, who was among the early warners on the risks of the now-withdrawn arthritis drug Vioxx, was concerned that the 25 cases might be just the tip of an iceberg. "There's no mandatory reporting of these cases," he says. He notes that the stimulants in question are known to raise blood pressure and heart rate. "Raising blood pressure of a child or adult continuously over many years worries me," Nissen told TIME. "There is a linear...
...boys diagnosed and treated for ADD," says FDA panel advisor Curt Furberg, a professor of public health at Wake Forest University, who voted in favor of the warning. "I don't argue that there are some kids who need that treatment, but it's probably overused." Doctors Furberg and Nissen are also concerned about the rising number of adults on these drugs. About 10% are over 50, a group that has a higher rate of cardiovascular problems to begin with. Says Dr. Nissen: "I want the physicians' hands to tremble a bit when they write a prescription for these drugs...
...idea here is if you know what happens in the highest risk individuals, you will know how to use the drugs in people at lower risk," said Nissen, who served on an FDA panel which last February recommended just such a study. "We will have 10 times the statistical power of any study ever done of these drugs." The results may thus indeed finally answer any lingering questions about how safe Celebrex is, something Pfizer no doubt hopes-but also fears...