- Prescribing Advice for GPs - https://www.prescriber.org.uk -

EMA starts rosiglitazone review

The European Medicines Agency has announced that it has started a review to determine whether new data on the risk of cardiovascular problems have an impact on the benefit-risk profile.

Rosiglitazone is available in the European Union as a single agent (Avandia®) and also in combination with metformin (Avandamet®) and glimepiride (Avaglim®).

In 2008 a similar review concluded that the benefit-risk profile remained positive but added new warnings to the product literature. The new warnings advised that clinicians must not use rosiglitazone in patients with acute coronary syndromes and should avoid use in patients with established ischaemic heart disease or peripheral vascular disease. This review may result in no change or in another change, revocation or suspension of the product licence.

Action: Clinicians should be aware of this review. The results of this review may lead to a product licence change.