FDA Restricts Use of Rosiglitazone, EMEA Recommends Suspension

ROCKVILLE, Md — September 23, 2010 — The US Food and Drug Administration (FDA) announced that it will significantly restrict the use of the diabetes drug rosiglitazone (Avandia) to patients with type 2 diabetes who cannot control their diabetes on other medications.

These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with rosiglitazone.

On July 14, 2010, the FDA Advisory Panel voted to keep rosiglitazone on the market despite concerns over associated heart risks — 20 members voted in favour, while 12 members voted to recommend that the FDA withdraw the drug.

Today, the European Medicines Agency (EMEA) recommended the suspension of the marketing authorisations for rosiglitazone-containing anti-diabetes medications in Europe (Avandia, Avandamet, and Avaglim). These medicines will stop being available in Europe within the next few months. Physicians should stop prescribing rosiglitazone-containing medicines.

The current review of rosiglitazone by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated on July 9, 2010, following the availability of new studies questioning the cardiovascular safety of the medicine.

Data from clinical trials, observational studies, and meta-analyses of existing studies that have become available over the last 3 years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone. Further restrictions on the use of these medicines in patients with ischaemic heart disease were introduced. The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk.

The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.

The suspension will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.

The Committee’s recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision.

SOURCE: US Food and Drug Administration and the European Medicines Agency