Two recent studies linking the diabetes drug Avandia to heart ailments prompted the U.S. Food and Drug Administration (FDA) to consider withdrawing it from the market.
A panel of experts from the FDA will meet next week to decide the fate of the GlaxiSmithKline (GSK) diabetes treatment with the generic name rosiglitazone.
Thomas Marciniak, an FDA expert on cardiovascular treatments, had claimed in a document that clinical trials of the Avandia was flawed because the study design was inappropriate and biased.
The two studies on the drug also concluded that users faced higher risk of heart attacks and strokes.
The FDA also has a 700-page study of Avandia's safety compared with other diabetes treatments.
In the market since 1999, Avandia became GSK's blockbuster drug with global sales last year reaching $800 million.