Wednesday, November 07, 2007

New restrictions on the use of rosiglitazone products due to cardiac safety concerns (Avandia, Avandamet, Avandaryl)

From Health Canada:

GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new restrictions on the treatment of type 2 diabetes mellitus with the rosiglitazone-containing products: AVANDIA® (rosiglitazone), AVANDAMET® (rosiglitazone and metformin), and AVANDARYLTM (rosiglitazone and glimepiride).

Further to a Health Canada assessment of adverse event reports, published articles* and other available information on congestive heart failure, myocardial infarction, and related events, the Canadian Product Monographs for rosiglitazone-containing products are being updated and will include the following new usage restrictions: ...more

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