April 9, 2008
FDA Sends Avandia Warning Letter
Calling company violations "serious", the FDA issued a sharply worded warning letter to the manufacturer of the diabetes drug Avandia for failing to file reports concerning clinical trials of the drug. The FDA ordered Glaxo Smith Kline to take immediate action to prevent future transactions.
The clinical trial reports are used by the FDA to quickly spot potential safety issues with drugs during their clinical stage. Avandia has been under intensified scrutiny since last year when the drug was associated with higher risk of heart attacks than oral diabetes medicines or placebos. Last November, the FDA ordered the black box warning to be placed on the diabetes drug.
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