Avandia Lawsuits
Avandia (rosiglitazone) is an oral anti-diabetic medication which is used to treat type 2 diabetes by increasing insulin sensitivity. Approved by the FDA in 1999, Avandia works to improve glycemic control while reducing circulating insulin levels in adult diabetic patients.
FDA Issues Safety Alert on Avandia
On May 21, 2007, the U.S. Food and Drug Administration (FDA) announced a potential health issue related to Avandia. Data collected from various controlled clinical trials have demonstrated an increased risk of heart attack and heart-related deaths in patients taking Avandia. However, the FDA is not asking GlaxoSmithKline, the manufacturer of the drug, to take any specific action at this time, as additional health risks are associated with abruptly switching diabetic patients from one form of medication to another.
Since Avandia was approved, the FDA has been monitoring several heart-related adverse conditions based upon data reported in previous clinical trials of Avandia alone and in combination with other drugs—some of these conditions reported included fluid retention, edema and congestive heart failure. Based upon this clinical data, the FDA has updated the product's labeling on several occasions, most recently in 2006. This updated labeling for Avandia included a new warning about a potential increase in heart attacks and heart-related chest pain in patients taking the drug.
Most recently, GlaxoSmithKline has provided the FDA with data based upon 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in type 2 diabetic patients. The collective data suggests that patients receiving short-term treatment with Avandia have a 43% greater risk of heart attack or developing other heart-related adverse conditions than patients treated with placebo or other therapy. If confirmed, this data would be of substantial concern, as diabetic patients already have an inherent risk of heart disease.
While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability."
If you or a loved one has experienced any health problems from taking Avandia, including heart attack and/or other heart-related adverse conditions, you should seek immediate medical counsel to discuss this emerging information on Avandia. You also have legal rights and should contact a qualified Avandia lawyer, as provided on this site, to discuss your litigation options. As all claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay. Please call today to arrange for an initial consultation.