Actos and Avandia Fracture Risk Doubled for Women

New research suggests that women who take the diabetes drugs Actos or Avandia could double their risk of bone fractures. When this risk is combined with the already established cardiovascular risks, it will certainly add to the growing debate over whether an Avandia recall should be issued.

 
Avandia (rosiglitazone), manufactured by GlaxoSmithKline PLC, and Actos (pioglitazone), manufactured by Takeda Pharmaceuticals North America Inc., are both part of the same class of medications, known as thiazolidinedione agents.

The drugs were previously very popular treatments for type 2 diabetics, used to control blood sugar levels. However, over the past 18 months, concerns have emerged about the safety of the drugs, especially Avandia.

The new study, which was published online December 9, 2008, by the Canadian Medical Association Journal, involved data on 14,000 patients from 10 prior drug trials.

Researchers from Wake Forest University School of Medicine found that the Actos and Avandia fracture risk among women was more than double the normal risk among women in the same age groups. For women in their 70’s who took one of the drugs for at least a year, approximately one out of every 20 had a chance of suffering a fracture. For women in their mid-50s, approximately one out of every 55 women had a risk of fracture with Avandia and Actos. The same increases in fractures was not found among men.

Both Avandia and Actos carry black box warnings about potential side effects which may increase the risk of congestive heart failure, and Avandia also contains information in the black box warning about a risk of heart attacks. Avandia side effects have also been linked to a potential increased risk of liver failure and vision loss, known as macular edema.

The American Diabetes Association and the European Association for the Study of Diabetes have unanimously recommended against the use of Avandia because of concerns about the heart risks, and last month the consumer group Public Citizen, filed a petition with the FDA calling for a recall of Avandia because of the substantial risks associated with the drug.

Given the risk of Avandia bone fractures, heart problems, liver failure and vision loss, many have questioned whether any minimal blood-sugar lowering benefits provided by the diabetes drug are worth the exposing individuals to the dangerous side effects.

In addition to the mounting evidence that suggests an Avandia recall may be issued, GlaxoSmithKline is also facing a growing number of Avandia lawsuits filed by individuals who allege that the drug maker has failed to adequately warn about the drugs risks.