Avandia

Alert Update: February 2011

Label Updates for Restricted Prescription

GlaxoSmithKline PLC has updated the labeling of its diabetes pill Avandia to include safety restrictions because of the drug’s link to an increased risk of heart attack. These updates were made in response to safety actions mandated by the Food and Drug Administration (FDA) in September 2010. The new U.S. label says that Avandia is only intended for patients who cannot control their blood sugar with any other type of diabetes medication currently on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.

What is Avandia?

Avandia is the brand name for rosiglitazone, a prescription drug manufactured by GlaxoSmithKline. Avandia was approved by the FDA in 1999 to treat Type 2 diabetes.

Overview of Avandia

Nearly one million U.S. patients filled prescriptions for Avandia in the first half of 2010 alone, and more than six million people have taken the drug worldwide (according to the health data firm IMS Health). There are more than a dozen prescription drugs on the market to treat Type 2 diabetes, but only Actos, a prescription medication made by Japan-based Takeda Pharmaceuticals, works the same way as Avandia. About 18 million Americans suffer from Type 2 diabetes.

It took many years to link Avandia with heightened heart attack risk, because most patients who take the drug are predisposed to heart disease or suffer from it already.

The FDA updated Avandia’s label in 2006 to include a warning about increased risk of heart attack and heart-related chest pain. This was based on findings from patients who already suffered congestive heart failure.

In May of 2007, studies were released that noted the increased rate of risk from taking Avandia. Patients on the drug had a 43 percent higher rate of heart attack and a 64 percent higher rate of death based upon a study of more than 27,000 people.

In August of 2007, the FDA placed a black box label on Avandia due to its connection to heart failure. In September of 2010, the FDA restricted Avandia prescriptions to patients whose Type 2 diabetes can’t be treated with other medication. The problems associated with Avandia have led to thousands of patient lawsuits and a Department of Justice investigation. The European Union has since banned the drug altogether.

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