The diabetes drug, rosiglitazone (Avandia®, GlaxoSmithKline), has been suspended in Europe, following a review of cardiovascular safety data by the European Medicines Agency (EMA).
In contrast, the US Food and Drug Administration (FDA) has allowed the drug to remain available, but only under a very stringent restricted-access programme.
Rosiglitazone has been under mounting scrutiny for several years now after a meta-analysis by Dr Steven Nissen (Cleveland Clinic, Ohio, US) suggested an increased risk of cardiovascular events in patients taking the drug.
The EMA says that doctors should stop prescribing rosiglitazone-containing medicines, and patients taking them should be reviewed in a timely manner to amend their treatment. Patients are advised not to stop their treatment without speaking to their doctor.
The suspension has come about because the agency believes that the benefits of rosiglitazone no longer outweigh its risks. The suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.
The two drug authorities also announced that further data on the safety of rosiglitazone is being sought from a readjudication of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) trial at the individual patient-data level.
A statement released by the FDA says that although there is a “signal of harm” with rosiglitazone, confirmation of the existence and magnitude of this harm has not been possible with available data. “If reliable information on ischaemic risk can be obtained from the readjudication of RECORD, the benefit/risk information for rosiglitazone should be reevaluated,” it adds.
Commenting on the different decisions taken by the EMA and the FDA, an EMA spokesperson attributed this to “differences in healthcare environments” between the US and Europe, noting that the FDA does not have the legal tool of suspension that is available in Europe.
And the US restrictions are thought to be harsh enough to ensure that use of the drug will be cut dramatically. Patients will only be allowed access to rosiglitazone if they are unable to achieve glycaemic control using other medications and, in consultation with their healthcare professional, decide not to take pioglitazone for medical reasons. Doctors will have to attest to and document their patients’ eligibility, and patients will have to sign statements that they understand the cardiovascular safety concerns.
An FDA spokesperson said: “We [the FDA and EMA] are taking somewhat different strategies, but both are trying to ensure the goal of safety.”
GlaxoSmithKline said: “The company continues to believe that Avandia® is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions”.