Rosiglitazone: new restrictions in Canada
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Rosiglitazone: new restrictions in Canada In collaboration with Health Canada, GlaxoSmithKline has issued a ‘Dear Health Care Professional’ letter1 and Press Release2 informing people of new restrictions on the use of the rosiglitazone-containing antidiabetic medications Avandia, Avandamet and Avandaryl.* These restrictions are a result of a review of data suggesting that Avandia increases the risk of cardiovascular events. The restrictions mean that Avandia, Avandamet and Avandaryl are now indicated only for patients with type 2 diabetes mellitus who cannot control their diabetes with other oral medications. * Similar restrictions have been announced by the US FDA, while the EMA has recommended the suspension of marketing authorisations for these medications. See Reactions 1321 p1; 801140883. 1. Reblin T. AVANDIA, AVANDAMET and AVANDARYL - Important new restrictions on the use of rosiglitazone products due to information on cardiovascular related events - for health professionals. Internet Document : [5 pages], 9 Nov 2010. Available from: URL: http://www.hc-sc.ga.ca. 2. Reblin T. AVANDIA, AVANDAMET and AVANDARYL - Important new restrictions on the use of rosiglitazone products due to information on heartrelated events - for the public. Internet Document : [4 pages], 18 Nov 2010. Available from: URL: http://www.hc-sc.ga.ca. 801157459
0114-9954/10/1329-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved
Reactions 27 Nov 2010 No. 1329
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