Other safety alerts
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| Statement on Rosiglitazone (Avandia, Avandamet) by Medicines and Healthcare products Regulatory Agency in United Kingdom |
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This is an update to the brief message which was published on the Medicines and Healthcare products Regulatory Agency (MHRA) website on 3 March following enquiries regarding completion of a two-year inquiry by a United States Senate committee, which had questioned the cardiovascular safety of the anti-diabetes medicine, Avandia (rosiglitazone). The available data considered during this US inquiry had previously been considered as part of Europe-wide reviews, which concluded that the balance of risks and benefits remains favourable. The prescribing information has been updated to include warnings about the risk of myocradial infarction and also to advise that, in patients with ischaemic heart disease, rosiglitazone should be used only after careful evaluation of every patient’s individual risk.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON079039
In Hong Kong, Avandia and Advandamet are registered by GlaxoSmithKline Ltd. Warnings about the risk of myocradial infarction have been included in the package inserts of Avandia and Advandamet. Any new findings about rosiglitazone will be kept in view.
Ends/Tuesday, April 20, 2010
Issued at HKT 14:30
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