The European agency that evaluates medicines is planning to review the safety of the diabetes drug Avandia after a study suggested it is linked to an increased risk of heart problems, strokes and deaths in older adults.
The European Medicines Agency revealed that the Committee for Medicinal Products for Human Use will review the future of the drug when it meets between 19 and 22 July.
Meanwhile the US Food and Drug Administration will hold hearings on Avandia, also known as rosiglitazone and made by GlaxoSmithKline PLC, this week.
Dr Tony Hoos, European Medical Director for GlaxoSmithKline, said: "GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate type 2 diabetes patients.
"It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients."
The European Medicines Agency has authorised the drug for use, but with warnings about prescribing for patients with heart failure or a history of heart failure, or to patients with heart problems.
A study published in the US last month linked Avandia to an increased risk of heart problems, strokes and deaths in older adults, claiming it is more dangerous than a rival drug, Actos.
As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, said Dr David Graham, lead author of the study and a scientist for the FDA.