- 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.
This entry was posted on Wednesday, December 12th, 2007 at 3:20 am and is filed under Avandia. You can follow any responses to this entry through the RSS 2.0 feed.
You can leave a response, or trackback from your own site.
December 13, 2007 at 4:20 am
we shouldn’t evaluate risks but that you have to weigh the risk against the reward.
December 13, 2007 at 4:50 pm
With safer alternatives out there, how can you justify putting your patent at risk?