EMA suspends rosiglitazone
The European Medicines Agency (EMA) recommended yesterday that marketing authorisation for the anti-diabetes drug rosiglitazone be suspended.
Analysis of the available data showed that the benefits of the drug no longer outweighed the cardiovascular risks, including an increased risk of heart attacks and strokes.
Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) Professor Kent Woods said: "Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone. Today's suspension means that clinicians should review all patients currently on rosiglitazone and take appropriate action, according to the individual clinical situation, to change to another suitable treatment."
Rosiglitazone, manufactured by Glaxosmithkline, was first authorized in the European Union in 2000 as a second-line treatment for Type 2 diabetes in patients for whom metformin was inappropriate, or as combination therapy with either metformin and/or sylphonylurea in patients with inadequate diabetes control.
There have always been concerns regarding the drug's cardiovascular safety, and it has been kept under close review.
Commenting on the latest decision, Donald Singer, from the British Pharmacological Society, said: "The recent experience with rosiglitzone points to the need for rigorous clinical trials to ensure that the best quality studies are available at the earliest possible stage... This is both particularly challenging and important for conditions like diabetes in which patients are already at high risk of complications from the underlying medical disorder."
A simultaneous decision to restrict use of rosiglitazone has been taken by the US Food and Drugs Administration.
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By Caroline Price