Rosiglitazone (Avandia) and cardiovascular events
admin June 20th, 2007
Over the past month the New England Journal of Medicine has published a meta-analysis and an interim results paper of the RECORD study concerned with the cardiovascular safety of rosiglitazone. There is coverage of both the meta-analysis and the trial data at prescriber.org.uk
Currently the MHRA and EMEA are not taking any action based on these results. Avandia is a centrally licensed drug, and therefore the European Medicines Agency has issued a statement about the cardiac safety of rosiglitazone. Patients are advised not to stop their treatment with rosiglitazone, but should discuss any concerns about their medication at their next routine appointment with the doctor. The statement is available at the MHRA website.
- ADRs , EMEA , MHRA
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