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Rosiglitazone (Avandia, Avandamet): Recommended withdrawal from clinical use

A Europe-wide review of the risks and benefits of medicines containing rosiglitazone has concluded that the benefits of treatment no longer outweigh the risks. The Chair of the Commission on Human Medicines (CHM) has written today to healthcare professionals to inform them of the advice of the CHM following this Europe-wide review.

The most recent review was triggered by new studies showing that rosiglitazone is associated with an increased risk of cardiovascular disorders, including heart attacks and heart failure.

The conclusion of the Europe-wide review is consistent with advice that the Medicines and Healthcare products Regulatory Agency (MHRA) has received from the Commission on Human Medicines saying that the scientific evidence shows that rosiglitazone is associated with an increased risk of cardiovascular disorders. The Commission on Human Medicines is an independent committee responsible for providing expert advice on drug safety.

The research has not identified any particular groups of patients for whom the benefits of rosiglitazone outweigh the risks. As such, rosiglitazone will cease to be available in Europe within the next few months. This will allow time for patients to consult with their doctor about switching to a suitable alternative medication.

Further information

Letter for healthcare professionalsPDF file (opens in new window) (25Kb)

Questions and answers for patientsPDF file (opens in new window) (63Kb)

Press statement

Current advice from the National Institute for Health and Clinical Excellence (NICE) (External link)

Page last modified: 24 September 2010