Avandia (rosiglitazone) is a widely prescribed medication approved in 1999 for the treatment of Type 2 diabetes. However it has been discovered that this drug causes heart attack and other heart related issues.
In a recent battery of 42 clinical studies, it was shown that Avandia increased patients’ chance of heart attack by 43 percent and cardiac-related death by 64 percent.
The Food and Drug Administration has issued several safety alerts, however, the drug is still being used by almost a million Americans.
â€¢ May 21, 2007 the FDA issued an alert that they were aware of a potential safety issue related to rosiglitazone maleate (Avandia, Avandamet, & Avandaryl). They stated that safety data from a pooled analysis of controlled clinical trials had shown a significant increase in the risk of heart attack and heart-related deaths in patients taking rosiglitazone.
â€¢ June 6, 2007 the FDA determined that rosiglitazone (Avandia, Avandamet, & Avandaryl) should carry a “black box” warning – FDA’s strongest form of warning.
â€¢ August 14, 2007 the FDA expanded the scope of the black box warning to emphasize that rosiglitazone (Avandia, Avandamet, & Avandaryl) may cause or exacerbate heart failure, particularly in certain patient populations.
â€¢ November 14, 2007 the FDA required GlaxoSmithKline to revise Avandia’s existing boxed warning to include the following statement:
â€¢ A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.
The main concerns for Avandia are heart attack and cardiac related death. However there are a few other telltale signs that lead up to these serious results.
Avandia users who are at risk have been known to experience weight gain, low blood sugar, edema, low red blood cell count, abnormal ovulation, and liver problems.
What You Can Do
If you or a loved one have experienced heart related issues as a result of taking Avandia (rosiglitazone), you may be entitled to monetary compensation. Please use our free lawyer consultation service or call 1-800-603-6833. All consultations are free of charge and will be answered as soon as possible.