FDA Alert – New Avandia^® Warning Information Reflects Possible Heart Attack Risk

The FDA informed healthcare professionals of new information about potential increased risk for heart attacks added to the existing boxed warning in Avandia's prescribing information. This new information refers to a meta-analysis of 42 clinical studies (most of which compared Avandia to placebo) that showed Avandia to be associated with an increased risk of myocardial ischemic events, such as angina, or myocardial infarction. At this time, the FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and other oral type 2 diabetes treatments.

The Bottomline:
People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning, as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.

Read the complete MedWatch 2007 Safety Summary including a link to the FDA News Release regarding this issue at:
www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia2

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