Update on Avandia; November 14, 2007
Food and Drug Administration (FDA) and GlaxoSmithKline (GSK), the makers of Avandia, have updated the drug’s safety information. The boxed WARNING was expanded to include information on heart problems, such as chest pain (angina) and heart attack (myocardial infarction). See Medication Guide for more information.
After careful review of Avandia patient data, FDA concluded that there is not enough evidence to show that the risks of heart attack or death are different between Avandia and some other oral type 2 diabetes medicines. Therefore, GSK has agreed to work with FDA to conduct a new long-term study to further review cardiovascular effects of Avandia. GSK is also developing a medication guide for patients to further understand how to take Avandia.
No oral type 2 diabetes drug has proven to decrease the risk of cardiovascular (heart) events. FDA will request that the labels of all oral type 2 diabetes drugs contain this language.
If you take Avandia
Be sure to discuss your health history with your doctor. FDA advises that people with type 2 diabetes who have heart problems or who are at high risk of heart attack should talk with their doctor about the revised warning as they evaluate treatment options. FDA advises doctors to closely monitor patients who take Avandia for risk of heart problems.
For more information, click Medication Guide.
Do not stop taking Avandia or any medicine without talking to your doctor. Click here for questions to ask your doctor.
Next: Some Facts About Avandia
