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Europe-wide Suspension of Marketing Authorisation for Avandia, Avandamet and Avaglim (rosiglitazone)

The European Medicines Agency’s (EMA) Committee on Medicinal Products for Human Use (CHMP) has today recommended the suspension of the marketing authorisation for Avandia because the benefits no longer outweigh the risks.

The CHMP looked at the available data for the benefits and risks associated with Avandia. The analysis showed that overall there was an increased risk of heart attacks and strokes.

Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Professor Kent Woods says: “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.”

To inform and input into the European debate, the MHRA conducted its own assessment of the safety of rosiglitazone and sought the advice of the UK’s Commission on Human Medicines (CHM). The CHM advised in July 2010 that the risks of rosiglitazone outweighed its benefits and that it no longer had a place on the UK market. In addition, the CHM considered action should be taken promptly and ideally within the appropriate EU framework and it is this process which has led to today’s suspension.

To read the full Press Statement click here.