Avandia must now carry "black box" warning
On November 14, 2007, the U.S. Food and Drug Administration announced that GlaxoSmithKline PLC's diabetes drug Avandia must now carry a "black box" warning so doctors and patients know about the increased risk of heart attacks in men and women who take the drug.
The new Avandia warning includes the following statement:
"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 new FDA-mandated labeling change follows a recommendation made in July 2007 by the FDA's Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Approved by the FDA in 1999, Avandia (rosiglitazone) was developed to help control blood sugar in adults with Type 2 diabetes. The drug has been used by nearly seven million people worldwide. Since the drug was approved, the FDA has monitored several heart-related adverse events associated with Avandia, such as fluid retention, edema and congestive heart failure. The FDA repeatedly has updated the product's labeling to reflect these concerns.
If you or a loved one has taken Avandia and suffered side effects, please contact our office for a free evaluation.
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