The Cochran Firm Legal Blog

Avandia and Actos are both drugs for treating type 2 (adult onset) diabetes. Avandia is offered by the British company GlaxoSmithKline and Actos is offered by Takeda Pharmaceuticals America, Inc. with Eli Lilly & Co. They have both been found to increase the risk of heart failure and in 2007, the FDA required them to have a black box warning to that effect. A black box warning is the strongest FDA warning.

They belong to a class of diabetes drugs (called thiazolidinediones or glitazones) that work by increasing the body’s sensitivity to insulin. Another drug in this class was Rezulin, which was withdrawn from the market in 2000 for causing liver disease fatalities.

In 2007, The Avandia and Actos companies separately issued warnings that their drugs can also increase the risk of broken bones in women.

A Harvard Study

The American Diabetes Association is planning to publish a study done recently by a group of Harvard researchers. The study covered the years from 2000 to 2006 and focused on the medical records of 26,375 diabetic patients who took Avandia. They were all patients at Boston area clinics and hospitals affiliated with Harvard Medical School.

The study compared this group with another group in the same time period who took Actos. Researchers were looking for reports of heart attack (myocardial infarction) and they found such reports nearly twice as often for patients on Avandia as for those on Actos.

Separate and Similar Studies

1. In a separate study done by GlaxoSmithKline and i3 Drug Safety (a drug safety firm), researchers found that the risk of heart attack among Avandia users is increased by 35 percent to 41 percent over that for Actos users. This study used the medical records of 47,501 patients for each of the two drugs and covered the years 2000 to 2007. It will be published in the journal Clinical Therapeutics shortly.
   
2. In 2003, the Mayo Clinic published the results of their Actos and Avandia study. This was a much smaller study but it involved live patients. The six patients had type 2 diabetes and took either Actos or Avandia. They all went to an emergency room complaining of congestive heart failure symptoms (shortness of breath, weight gain, swollen feet) and four of them also had chronic kidney trouble.

As a result of this study, The American Heart Association and American Diabetes Association have issued guidelines for use of the glitazone group of drugs. They are warning the public that if you have mild heart disease or any kidney problems and you take any of these drugs, you may have increased risk of developing congestive heart failure.

About 13,000 people have filed claims against GlaxoSmithKline after using Avandia and suffering a heart attack. An unknown number have also filed against Eli Lilly and Takeda. However, the FDA has so far refused to order these drugs withdrawn from the market.

If you have been harmed by a defective drug and are wondering whether you might have a valid legal claim against the drug manufacturer, please contact our law firm today. Our lawyers work out of offices nationwide and we will be happy to schedule a free case review for you.

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