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U.S. Department of Health and Human Services

Safety

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Avandia (rosiglitazone maleate) Tablets November 2007

Audience: Cardiologists, endocrinologists, other healthcare professionals, consumers
[UPDATE 11/19/2007] Information for Healthcare Professionals Sheet highlights changes to the prescribing information for rosiglitazone, including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the product's prescribing information about the potential increased risk of myocardial ischemia.

[Posted 11/14/2007] FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The 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, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. 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.

[November 19, 2007 - Information for Healthcare Professionals - FDA]
[November 14, 2007 - News Release - FDA]