The agency reminds healthcare professionals that rosiglitazone:
- Must not be used in patients with heart failure, history of heart failure, or acute coronary syndrome.
- Is not recommended in patients with ischaemic heart disease or peripheral arterial disease.
- Should be used with insulin only in exceptional circumstances and under close supervision.
Patients being treated with rosiglitazone should be monitored for signs of fluid retention, including weight gain and cardiac failure. Treatment should be discontinued if cardiac status deteriorates.
The debate over rosiglitazone’s adverse cardiovascular effects has been fuelled by recent publications, including a retrospective cohort study and a meta-analysis of randomised controlled trials, pointing towards an increased risk of myocardial infarction and other cardiovascular events for rosiglitazone compared with both placebo and pioglitazone.
Updated 24 September 2010
On 23 September 2010, the European Medicines Agency recommended the suspension of marketing authorisation for rosiglitazone-containing drugs.