" The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack. "

" Glaxo officials, meanwhile, disputed that claim, citing their own analyses of studies of Avandia, also called rosiglitazone. "

" "The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Dr. Ronald Krall, the company's senior vice president and chief medical officer. "

" The FDA isn't required to follow the advice of its advisory committees but usually does. "

" The FDA moved up the date of Monday's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication. "

" Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos. The FDA's Graham, in his presentation, said Avandia does increase heart risks --
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