IMB confirms suspension of anti-diabetes medicines containing rosiglitazone
23 September 2010
The Irish Medicines Board (IMB) today confirms that in line with the European Medicines Agency (EMA) recommendation, rosiglitazone-containing anti-diabetes medicines (Avandia, Avandamet and Avaglim) will no longer be available for clinical use in Ireland due to concerns regarding cardiovascular safety.
Patients who are currently taking these medicines should make an appointment with their doctor to review their treatment. Patients are advised not to abruptly stop their medication without consulting their doctor. Doctors are advised not to issue any new or repeat prescriptions of rosiglitazone-containing medicines.
The IMB was a national participant in a European review which concluded today at 4.30pm that the risks of rosiglitazone containing medicines outweigh their benefits. In the interests of patient safety, the recommendation is that the marketing authorisation for rosiglitazone-containing medicines should be suspended across the European Union. This recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision.
Please note the following advice, which has been issued by the IMB in relation to the suspension of all authorisations for medicines containing rosiglitazone:
Advice to Patients and Carers:
- Patients should consult their doctor to review their treatment and should not abruptly stop their medication without advice from their doctor.
Advice to Doctors:
- Prescribers are advised not to issue any new or repeat prescriptions for rosiglitazone-containing medicines.
- Prescribers are advised to review currently treated patients and switch to suitable alternative treatment.
Advice to Pharmacists:
- Pharmacists are advised to refer patients to their doctor for advice on their treatment.
Download IMB Press Release
Further information, including a Questions and Answers document, is available from the EMA Website.
Patients and healthcare professionals who have any queries can contact the IMB on (01) 676 4971.
Ger McCarthy/Orla Molloy (Weber Shandwick)
Tel: (01) 676 01 68
Mobile: 086 233 3590 or 087 770 5108