A report prepared by a Food and Drug Administration (FDA) scientist in preparation for next week’s meeting to decide the fate of controversial Type 2 diabetes drug Avandia suggested that a recent study from Avandia’s maker did not provide any reassurance that the drug is safe, according to a recent article from USA Today.
Thomas Marciniak, a medical team leader in the Division of Cardiovascular and Renal Products, wrote that the study’s methodology was flawed and provided researchers with information that could bias the results. It also didn’t include data about which study participants died.
Avandia has come under significant criticism after claims that it increased the risk of heart troubles among its patients. The first concerns over the drug surfaced a few years ago, but a Senate Finance Committee found earlier this year that the drug’s makers, GlaxoSmithKline knew of the potential risks before the concerns surfaced publicly.
The FDA will ask an advisory panel next week what to do about the drug. Panel members will have five options to choose from, ranging from pulling the drug from the market, to keeping it on the market and removing the heart attack warning from the label, and a number of options in between.
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