Another Study Links Bone Fractures with Avandia and Actos

A new study reports that use of thiazolidinedione diabetes drugs, which include Actos and Avandia, may increase the risk of bone fractures 1.5 times, confirming the findings of early studies about the potential risk of bone fractures with Avandia and Actos.

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.

The study, published in the September 29 online edition of PLoS Medicine, is the latest in a series of studies linking the once-popular drugs to bone fractures. Researchers from the London School of Hygiene and Topical Medicine looked at a database of 6 million patients in the U.K. and examined 1,819 people over the age of 40 who had been prescribed a thiazolidinedione and subsequently suffered a bone fracture.

After adjusting their findings for the likelihood of bone fractures due to age, researchers compared the number of fractures patients suffered while on Avandia or Actos to the amount of fractures they reported while not on the medication. They concluded that patients have a 1.5 times higher risk of a bone fracture on Avandia or Actos, and the risk is essentially the same with both drugs.

The Avandia fracture problems are one of several safety concerns associated with GlaxoSmithKline’s drug, which many consumer advocates indicate should be removed from the market because of the risk of serious and potentially life-threatening problems. Other side effects of Avandia could include 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 risk of heart attacks from Avandia, which some experts estimated could be responsible for as many as 100,000 heart attacks since the drug was first introduced.

Glaxo faces thousands of lawsuits over Avandia 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.