Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
| This safety message has been superseded by a message issued on 23 September 2010 |
6 September 2010
As of July 2010, an ongoing Europe-wide review of the risks and benefits of rosiglitazone (external link) was initiated due to concerns about cardiovascular safety. This review follows new published data that raise concern about an increased risk of cardiovascular adverse effects of rosiglitazone. These data add substantially to existing evidence and point towards an increased cardiovascular risk with rosiglitazone compared with both placebo and with pioglitazone.
The MHRA is contributing to current EU assessment of rosiglitazone which is anticipated to reach its conclusion within the next month.
European Medicines Agency update on ongoing benefit-risk review of Avandia and Avandamet
While the European review is ongoing, healthcare professionals are reminded to closely observe the current contraindications and monitoring requirements for rosiglitazone, and to consider alternative treatments where appropriate.
Further information for healthcare professionals has been circulated via the Central Alerting System (CAS). The most recent information issued by the MHRA was:
Information on rosiglitazone and cardiovascular risk circulated on 26 July 2010 via CAS
(97Kb)
Patients are reminded of the importance of attending their routine appointments to monitor their diabetic care.
Further information for patients is provided in this Q&A document (28Kb)
Further information
Glitazones for diabetes
Diabetes UK (external link)
Full prescribing information for rosiglitazone (external link)
Previous MHRA advice in Drug Safety Update articles:
Drug Safety Update: Volume 1, Issue 7, February 2008
Drug Safety Update: Volume 1, Issue 5, December 2007
26 July 2010
New data have been published that raise concern about an increased risk of cardiovascular adverse effects of rosiglitazone. These data add substantially to existing evidence and point towards an increased cardiovascular risk with rosiglitazone compared with both placebo and with pioglitazone.
There is currently an ongoing Europe-wide review of the risks and benefits of rosiglitazone due to these concerns.
European Medicines Agency update on ongoing benefit-risk review of Avandia and Avandamet.
While the European review is ongoing, healthcare professionals are reminded to closely observe the current contraindications and monitoring requirements for rosiglitazone, and to consider alternative treatments where appropriate.
Patients are reminded of the importance of attending their routine appointments to monitor their diabetic care.
Further information for healthcare professionals has been circulated via the Central Alerting System (CAS).
Information on rosiglitazone and cardiovascular risk circulated via CAS (97Kb)
Further information
Full prescribing information for rosiglitazone (external link)
Previous MHRA advice in Drug Safety Update articles:
