EMEA: Avandia/Actos benefits outweigh risks

The European Medicines Agency (EMEA) says that the therapeutic benefits conferred by the antidiabetics Avandia (rosiglitazone), marketed by UK drug major GlaxoSmithKline, and Actos (pioglitazone), co-developed by Japan's Takeda and US drugmaker Eli Lilly, outweigh any associated risks. The announcement follows concerns about the well-documented link between thiazolidinedione-based products and cardiovascular problems (Marketletters passim).

The EMEA said that, having conducted a detailed review of the relevant data, which examined the compounds in terms of both cardiovascular effects and the possible risk of bone fractures in female patients, the drugs are still suitable for the treatment of type 2 diabetes. However, the agency also said that the prescribing information provided with the products should be updated to include a warning that patients suffering from ischemic heart disease should only use them on completion of a comprehensive risk evaluation.

GSK's vice president and European medical director, Alastair Benbow, commented that the EMEA "recognizes the positive benefit/risk of rosiglitazone in Europe and its importance in the treatment of type 2 diabetes." Dr Benbow added that the company was confident in the safety of the product when used appropriately by physicians.