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.
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.
Then again on February 22, 2010, the FDA issued another safety alert about Avandia. This time, the FDA announced it would be reviewing data from the long-term "RECORD" study (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes). The RECORD study was conducted specifically to evaluate the cardiovascual safety of Avandia.
Since Avandia was approved, the FDA has continually monitored several heart-related adverse conditions based upon data reported in previous clinical trials of Avandia, the RECORD study, several other observations studies, and other data. The studies indicated occurreances of health conditions associated with the use of Avandia, including fluid retention, edema and congestive heart failure. Based upon this clinical data, the FDA updated the product's warning label on several occasions, most recently in 2006. While the FDA Advisory Committe voted not to withdraw Avandia from the market at that time, relying instead on an updated warning label, concerns over the safety of Avandia and the increased risk of heart attack and other cardiovascular problems remained.
GlaxoSmithKline provided the FDA with data based upon controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in type 2 diabetic patients. GlaxoSmithKline's data suggested 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. However, other reports from the medical community indicate GlaxoSmithKline's studies may not have been correctly performed, or worse that their data may not have included all of the negative risks of the drug. As such, the FDA Advisory Committe reconvened in July 2010 to review the more recent data and determine if Avandia should be recalled from the market. In addition, the Advisory Committe would be evaluating whether GlaxoSmithKline suppressed negative information about the drug's safety.
On July 13 and 14, 2010, the FDA Advisory Committe convened to review a substantial amount of data on the safety of Avandia given the cardiovascual risks of the drug. The panel was divided on many of the issues, particularly because they found that Avandia does raise the risk of heart attack more than other medications of its kind. However, the panel vote ultimately weighed in favor of Avandia staying on the market, but with tightened controls. On the critical and controversial issue of whether or not Avandia should remain on the market, 12 members voted for pulling the drug, 17 voted for new warning label revisions or restrictions on use, and three voted that no changes were needed. Many of the panel members voted to pull the drug because they found that another diabetes drug, Actos, was substantially safer than Avandia with regard to cardiovascular risks. In fact, the panel voted 21-4 that Avandia is more likely to cause heart attack than Actos. Nevertheless, the panel ultimately decided to keep it on the market. However, the FDA is not required to follow the committee's recommendation and will issue its final ruling in the coming months.
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.
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