ARTICLE | Clinical News

Avandia rosiglitazone regulatory update

November 22, 2010 8:00 AM UTC

Health Canada restricted use of Avandia from GlaxoSmithKline after a review of data that suggested an increased risk of cardiovascular events associated with the diabetes drug. Avandia will now only be available for patients in Canada when all other oral drugs have failed to produce glycemic control, or are not appropriate. Avandia's label also will now include a boxed warning regarding the risk of serious heart problems, including heart failure, angina, heart attack and fluid retention. Additionally, physicians will be required to complete a patient informed consent process prior to starting or renewing a prescription for Avandia. ...