NOTE: Labels in bold are required.
Avandia (rosiglitazone) Update - Boxed Warning For Heart Attacks Added To Anti-Diabetes Drug Prescribing Information
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.
Read the complete MedWatch 2007 Safety Summary including a link to the FDA News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia2
MedWatch- the FDA Safety Information and Adverse Event Reporting Program
