Avandia and Avandamet marketing authorisations suspended

The European Medicines Agency's (EMA) Committee on Medicinal Products for Human Use (CHMP) has recommended that the marketing authorisation for Avandia (rosiglitazone) and Avandamet (rosiglitazone + metformin) be suspended across the European Union.

European Medicines Agency suspends marketing authorisation
European Medicines Agency suspends marketing authorisation
The EMA recommendation follows a Europe-wide review of available data, at the request of the European Commission, following reports of an increase in the risk of cardiovascular problems with rosiglitazone.

The CHMP concluded in its review that the benefits no longer outweigh the risks and that they could not identify additional measures that would reduce the cardiovascular risk.

Key recommendations:

  • Prescribers should put into place a system to review all patients currently prescribed Avandia or Avandamet, and change them to another suitable treatment in line with NICE recommendations. (See MIMS summary of NICE guidance on type 2 diabetes)
  • This change can occur at the next routine appointment or prescribers may wish to see patients sooner rather than later to reduce patient anxiety.
  • Patients taking rosiglitazone-containing medicines should consult their doctor about alternative treatment.
  • Patients should not stop taking Avandia or Avandamet without consulting their doctor.

View EMA report

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