Federal advisers delivered a mixed verdict Wednesday on the diabetes drug Avandia, with a significant number of experts voting to recommend that it be pulled from the market because of safety concerns but a majority urging to keep it available.
A panel of Food and Drug Administration advisers voted 20-12 to keep the pill available. But 10 also called for limiting who can receive and prescribe the much-debated medication.
It marks a tough win for British drug maker GlaxoSmith-Kline, which is facing thousands of lawsuits from patients who say Avandia caused their heart attacks or strokes. But sales of Avandia are likely to shrink to minuscule levels. FDA officials said they would make a decision as soon as possible.
NEW ALZHEIMER'S DIAGNOSTICS URGED
For the first time in 25 years, medical experts are proposing a major change in the criteria for Alzheimer's disease, part of a new movement to diagnose and, eventually, treat it earlier. The new guidelines, presented by experts convened by the National Institute on Aging and the Alzheimer's Association, would mean that new technology such as brain scans would be used to detect the disease even before there are evident memory problems or other symptoms. If the guidelines are adopted this fall, as expected, some experts predict a two- to threefold increase in the number of people with Alzheimer's. More than 5 million Americans have the disease.
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