Rosiglitazone: recommended withdrawal from clinical use

Suspension of the marketing authorisations of rosiglitazone (Avandia, Avandamet) recommended across the European Union.

Article date: October 2010

The European Committee on Medicinal Products for Human Use has recommended the suspension of the marketing authorisations of rosiglitazone (Avandia, Avandamet) across the European Union.

The UK Commission on Human Medicines has reviewed the available data and has concluded that there is an increased cardiovascular risk for rosiglitazone. It has not been possible to identify additional measures that would reduce the cardiovascular risk or to identify a patient population in whom the benefits continue to outweigh the risks. The Commission has therefore concluded that the benefits of rosiglitazone no longer outweigh its risks.

Advice for healthcare professionals and patients:

  • prescribers should put in place a system to ensure that all patients are reviewed and changed to another suitable treatment in line with NICE recommendations
  • while this change could happen at the next routine appointment, prescribers may wish to see patients sooner rather than later in order to reduce patient anxiety
  • patients who are concerned should not stop their treatment but should contact the healthcare professional supervising their diabetic treatment

Further information is available; see also letter for healthcare professionals sent Oct 1, 2010

Article citation: Drug Safety Update Oct 2010, vol 4 issue 3: S1.

Published 11 December 2014