In May, 2007, the FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone) citing and analysis of safety data which showed increases risks of rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. This was followed by an article in a prominent medical journal released in June, 2007 reported that the use of Avandia (rosiglitazone) was associated with a significantly increased risk of heart attack.
On July 30, 2007 an Advisory Committee of the Food and Drug Administration agreed with the earlier warnings, saying that Avandia was associated with a greater risk of myocardial ischemic events (including heart attacks) than a placebo. As a result, the FDA required a stronger warning on Avandia's warning label.
In November 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."
A press release by GlaxoSmithKline in February 2007 noted that there is a greater incidence of fractures of the upper arms, hands and feet in female diabetics given rosiglitazone compared with those given metformin or glyburide
If you or a loved one took Avandia and suffered a heart attack, stroke or other serious injury, you may have legal rights. Simply fill out the form at the right for a free consultation.
By filling out this free consultation form, you are NOT forming an attorney-client relationship. You can only retain an attorney by entering into a fee agreement. By submitting this form you not entering into a fee agreement. This form is just a request for legal advice. Any information that you will receive in response to the above question is general information and you will NOT be charged for the response to this e-mail question. THIS IS AN ADVERTISEMENT, Niche Marketers Network, Inc. is not a Lawyer referral service. Not available in all states, including FL. Privacy | Disclaimer