Actos and Avandia Bone Fracture Risk Increased 43%

A new study confirms concerns that side effects of the diabetes drugs Actos and Avandia significantly increase the risk of bone fractures.

The study by Medco Health Solutions Inc. (MHS) and the University of Texas Health Sciences Center, which was presented at a conference of the American Diabetes Association on Sunday, found a 43% increase in the risk of bone fractures among users of Avandia (rosiglitazone) and Actos (pioglitazone). Researchers also found that women were twice as likely as men to suffer bone fractures from Avandia and Actos.

While there have been concerns over Avandia bone fracture side effects for several years, the study confirms that Actos carries a similar risk. Both drugs are a type of diabetes medication known as thiazolidinedione agents, or TZDs. Combined, the medications have been used by an estimated 4 million Americans.

The new study involved the analysis of data for about 144,000 patients over an 18-month period. It found that most of the Actos and Avandia bone fractures affected the hands, wrists, legs and ankles, but there were also a few involving the hip or spine. The loss of bone strength can happen quickly; in about six months, and appears to be an effect of all TZDs, researchers said.

“When analyzed by gender, women on a TZD were 55 percent more likely to experience a bone fracture than women not on a TZD; men on a TZD had a 26 percent higher likelihood of suffering a fracture,” according to a MHS press release. “The findings support previous assertions that TZDs increase the risk of fractures.”

The bone fracture risks are just part of a multitude of health concerns that have plagued the type 2 diabetes drugs, and Avandia in particular. The drugs have been linked to an increased risk of congestive heart failure and

other cardiovascular problems.

Sales of Avandia plummeted in 2007, when the drug was linked to an increased risk of heart attacks and death. Since then, additional concerns have been raised about a risk of liver failure and vision loss associated with macular edema, and a petition has been filed with the FDA to issue an Avandia recall because of the potentially fatal side effects.

GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by individuals who allege that the drug maker failed to adequately study their medication or warn about the serious side effects. Many of the cases have been consolidated in an MDL, or Multidistrict Litigation, which is pending in the U.S. District Court for the Eastern District of Pennsylvania.