Notice type: Advisory
Rosiglitazone was first authorised in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient. Use of rosiglitazone-containing medicines has been contra-indicated in patients with heart failure or a history of heart failure since its first authorisation. Since then, the use of these medicines has been closely monitored and further restrictions and warnings regarding their use in patients with cardiac problems have been introduced.
A further review of rosiglitazone was initiated at EU level in July 2010 following publication of studies raising additional concerns regarding cardiovascular safety.
As additional, new data have very recently become available, these data will also be assessed at EU level, together with all other available data on the benefits and risks of rosiglitazone to allow the finalisation of the current review by September 2010.
While the Committee for Medicinal Products for Human Use (CHMP) is reviewing all available evidence on rosiglitazone, the following advice has been issued to healthcare professionals:
The Irish Medicines Board has also issued a Direct Healthcare Professional Communication (28 July 2010).
Advice to patients:
European Medicines Agency issues interim update on ongoing benefit/risk review of rosiglitazone–containing medicines Document