Avandia, Avandamet (rosiglirazone): withdrawal from the market

The firm GlaxoSmithKline, the marketing autorisation (MA) holder for Avandia and Avandamet, decided to remove these medicines from the Belgian market following the recommendation of the European Medicines Agency (EMA) to suspend their marketing authorisation, due to the increased cardiovascular risk associated with their use.

The FAMHP published on 23/09/2010 a communiqué concerning the recommendation of the EMA to suspend the marketing authorization for rosiglitazone-containing medicines marketed in Belgium under the name Avandia (rosiglitazone) and Avandamet (combination of rosiglitazone and metformine).

In this communiqué it was recommended to patients treated with these medicines to make an appointment with their doctor to discuss suitable alternative treatments and to doctors to stop prescribing these medicines and to contact their patients to amend their treatment.

An announcement of withdrawal of Avandia and Avandamet was communicated by the firm GSK to the Belgian Pharmaceutical Association and the FAMHP. These medicines have not been available since 01/11/2010.

Patients who have not yet contacted their doctor are encouraged to do so as soon as possible to adapt their antidiabetic treatment. They are advised not to stop their treatment without speaking to their doctor.


Contact: vig@afmps.be

Last updated on 05/01/2011