The European Medicines Agency (EMA) will be reviewing the safety of diabetes drug Avandia (rosiglitazone), manufactured by GlaxoSmithKline, following recent research suggesting it may be linked to a higher risk of heart problems, strokes and death in older people.
The EMA will meet to conduct the review by its Committee for Medicinal Products for Human Use (CHMP) when it meets from 19th-22nd July. The U.S Food and Drug Administration (FDA) are holding talks on the same issue this week.
Dr David Graham, lead author of the recent 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 has called for it to be banned.
It’s not the first time that speculation has surfaced surrounding the drug. The FDA convened advisory committees to review the efficacy and safety of rosiglitazone back in 2007. Back then it was decided it was safe to remain on the market, but controversy has resurfaced again since the beginning of the year.
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. Diabetes is a chronic, long term condition with serious consequences, and patients should not stop taking rosiglitazone, or any other medicine for type 2 diabetes, without consulting their doctor.’
The Medicines and Healthcare products Regulatory Agency (MHRA), who are responsible for the licensing of drugs in the UK, currently state that glitazones are a safe and effective treatment for Type 2 diabetes. In the UK they are not presently recommended for people who have had, or who are at high risk of having, heart failure.
People with diabetes are advised not to stop taking their diabetes medication without consultation with a doctor. If you are worried please see your diabetes healthcare professional.