Word: box
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...PENALTY BOX...
...proposal based on new data? No. The panel had been tasked with suggesting studies to explore the cardiovascular effects of these drugs. The idea of adding a "black box" warning came as a surprise...
...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 Nissen, who was among the early warners on the risks of the now-withdrawn arthritis drug Vioxx, was concerned that the 25 cases might be just the tip of an iceberg.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...
...clearly wasn't expecting such a bomb to go off in a routine meeting, but now the agency must deal with the fallout. A black box warning is unlikely. "We don't feel the risk is well enough established," said Dr. Laughren. But studies of the cardiovascular effects of these drugs are likely to get underway, and, given how many Americans are already taking them, they are probably long overdue. The FDA will also weigh a unanimous recommendation by the panel to make potential risks to the heart more apparent in the patient guides given out by pharmacies. That topic...
...Those who disagree and want a strong warning may not get their black box, but they've accomplished their goal of alerting patients to possible risks. Last week's flurry of headlines took care of that