Risk of Actos and Avandia Fractures Increased for Men and Women: Study

The findings of a new study appear to add to the evidence that the side effects of Avandia and Actos, two diabetes drugs in a class of medications known as thiazolidinediones, could cause users to suffer debilitating bone fractures, finding that both men and women who take the drugs could be at an increased risk.

Concerns over Actos and Avandia fractures have existed for some time, but recent studies, including the most recent study published in the Archives of Internal Medicine, have begun to quantify and confirm those suspicions. The newest report, which is the largest to date, studied the fracture rates of diabetics using thiazolidinediones, which includes Avandia (rosiglitazone) and Actos (pioglitazone).

The study looked at 84,339 patients from British Columbia, Canada, and compared the bone fracture rates of patients on thiazolidinedione with those taking another class of antidiabetic drugs known as sulfonylureas. Both classes of drugs are prescribed for the treatment of type 2 diabetes, and researchers found users of Actos and Avandia faced a 28% increased risk of fractures.

Avandia is manufactured by GlaxoSmithKine PLC, and Actos is manufactured by Takeda Pharmaceuticals North America, Inc.

The Avandia fracture risk is one of several safety concerns associated with GlaxoSmithKline’s drug, which have caused many to call for it to be removed from the market. Other studies have indicated Avandia side effects could also increase the risk of heart attacks, congestive heart failure, liver failure and a type of vision loss known as macular edema.

The FDA added a “black box” warning in 2007 regarding the Avandia heart attack risk, which some experts say could be responsible for as many as 100,000 heart attacks since the drug was first introduced.

The consumer group Public Citizen filed a petition with the FDA last year calling for an Avandia recall, indicating that the risks associated with the medication outweigh any potential benefit provided over other available medications. The American Diabetes Association, European Association for the Study of Diabetes and other experts have also questioned the continued use of Avandia.

GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by individuals who allege that the drug maker failed to adequately research their medication or warn about the serious side effects. In federal court, the Avandia litigation is consolidated in an MDL, or Multidistrict Litigation, in the U.S. District Court for the Eastern District of Pennsylvania for pretrial litigation.