Women Face Increased Risk of Fractures from Avandia and Actos: Study

A new study indicates that diabetic women, particularly those over the age of 65, face an increased risk of a bone fracture from Avandia and Actos. 

The study, published in this month’s issue of the Journal of Clinical Endocrinology & Metabolism, found that the risk of a bone fracture from Avandia and Actos can be as much as 70% higher among women taking one of the diabetes drugs. The bone fracture risk is just one of a number of side effects associated with Avandia, which have led some critics to call for an Avandia recall.

Avandia (rosiglitazone), manufactured by GlaxoSmithKline PLC, and Actos (pioglitazone), manufactured by Takeda Pharmaceuticals North America Inc., are both part of a class of medications known as thiazolidinedione agents, which are used to treat type 2 diabetes by helping control blood sugar levels.

Researchers from Henry Ford Hospital in Detroit, Michigan, looked at more than 19,000 individuals with diabetes who had been prescribed an oral diabetes medication. They found that women, on average, had a 50% higher chance of bone fractures when taking Avandia or Actos, and women over 65 saw their risk increase to 75%. Men did not appear to suffer the same increased risk of fractures from Avandia or Actos. For women, the increased risk began to appear about a year after they began treatment with the drugs.

The new study is just the latest blow for GlaxoSmithKline’s drug, as Avandia side effects have also been linked to an increased risk of heart attacks, congestive heart failure, macular edema, liver failure and death.

In October 2008, the consumer interests group Public Citizen filed a petition with the FDA calling for the drug to be banned, arguing that the risk of problems from Avandia outweigh the potential benefits. The FDA has not yet taken any action on the petition.

Glaxo faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania.