As per the recommendations made by the European regulators, GlaxoSmithKline (GSK) will revise labelling on its diabetes product Avandia to include additional warnings that the product may be associated with an increased risk of heart attacks.
The label will be revised to state that available data indicate that rosiglitazone may be associated with an increased risk of myocardial ischaemic events. It will also state that this risk was not confirmed or excluded in three long-term clinical trials and the data in their entirety on myocardial ischaemia are inconclusive.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) completed a positive benefit risk review of the thiazolidinediones (TZDs) including rosiglitazone in October 2007 and these label amendments are the result of this process.
There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease, especially those with myocardial ischaemic symptoms. The revised label will state that as a precaution, the use of rosiglitazone is not recommended in these patients. This information will appear in the warnings and precautions section of the label.
Patients with acute coronary syndrome (unstable angina, NSTEMI and STEMI) require urgent hospital treatment and have an increased risk of developing heart failure. This high-risk patient population has not been studied in rosiglitazone controlled clinical trials, and revised labelling will advise prescribers that rosiglitazone is contraindicated in patients with acute coronary syndrome.
"The EMEA has previously concluded that the benefits of rosiglitazone continue to outweigh its risks. The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone," said Dr Alastair Benbow, vice president and European medical director, GSK.
The label changes will be applied to all approved rosiglitazone-containing products: Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride) and Avaglim (rosiglitazone maleate and glimepiride).
"Long-term glycaemic control is important to help prevent the serious complications of diabetes, especially microvascular complications leading to blindness, amputation and kidney failure. Rosiglitazone has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines, metformin and glibenclamide (a sulfonylurea) - for nearly five years. Rosiglitazone is a valuable medicine for many patients with type 2 diabetes and remains an important treatment option for physicians." added Dr Benbow.
Rosiglitazone helps improve blood sugar control in Type 2 diabetes. It may be taken alone by diabetic patients who cannot take metformin, in combination with metformin or a sulphonylurea, or with both metformin and a sulphonylurea. It is contraindicated for use in combination with insulin.