A controversial diabetes drug treatment will be reviewed amid concerns that it is linked to an increased risk of heart problems and stroke, a European health authority has said.
Avandia, also known as rosiglitazone, will be subject to scrutiny by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) later this month following suggestions that the drug, commonly used by Type 2 diabetes patients, could be putting users at a higher risk of developing potentially fatal heart problems.
The GlaxoSmithKline-developed treatment will also be put under the spotlight by the US Food and Drug Administration (FDA) this week following the publication of a study last month, which reportedly exposed the risk the drug posed, claiming it was more dangerous than a rival treatment, Actos.
Dr David Graham, lead author of the study and a scientist for the FDA, said as many as 100,000 heart attacks, strokes, deaths and cases of heart failure may have been directly caused by Avandia since 1999 and called for it to be banned.
However, the drug’s manufacturer has defended the use of Avandia, saying the treatment has already undergone extensive testing over its safety and efficacy.
Dr Tony Hoos, European medical director for GlaxoSmithKline (GSK), 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.”