The EMEA has issued a statement in response to an article published in the New England Journal of Medicine (NEJM), which raised concern about a small increased risk of MI and cardiovascular death in patients with type 2 diabetes treated with rosiglitazone. The agency notes that:
• Most of the studies included in the NEJM paper have already been assessed by the EMEA’s Committee for Medicinal Products for Human Use (CHMP).
• The EU product information was updated in September 2006 with information about the risk of cardiac ischaemic events.
• Some of the studies in the NEJM paper included patients who were not treated in line with the indication approved in the EU.
Furthermore CHMP has kept rosiglitazone under close surveillance for cardiovascular effects (cardiac failure and other cardiac disorders including MI) since the drug was first approved in the EU in 2000.
The EMEA reminds prescribers to adhere to the restrictions for use in patients with cardiac disease as set out in the product information and advises patients not to stop treatment with rosiglitazone and to discuss the medication with their doctor at their next regular visit. The MHRA has issued a similar statement.
National Electronic Library for Medicines 24/5/2007