Avandia, Actos Raise Fracture Risk for WomenDec 10, 2008 | Parker Waichman LLP
Women who take the diabetes drugs Avandia and Actos face a higher risk of bone fractures, a new study has found. The fracture problem is just the latest troubling side effect associated with these drugs, which have also been linked to heart problems.
For the study, researchers at North Carolina's Wake Forest University School of Medicine and the University of East Anglia in Britain analyzed 10 previous clinical studies lasting at least a year involving 14,000 patients. According to USA Today, the researchers determined that taking either Avandia or Actos for a year doubled the risk of fractures in women. For those in their 70s, - a group already at a higher risk for fractures - the researchers estimated that one fracture would occur for every 21 women. In women in their mid-50s, the figure equals one fracture in every 55 women.
No increased risk was seen among men who took Avandia or Actos. The researchers speculated that the drugs' interaction with estrogen may have led to weaker bones in women. They called for stronger warnings on drugs' labels about the increased fracture risk.
Both Avandia and Actos are associated with other serious side effects. The labels of both drugs carry strong warnings about their link to heart failure. In May 2007, an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking Avandia had a 43-percent higher risk of having a heart attack. In November 2007, the Food & Drug Administration (FDA) finally ordered that a black box warning detailing Avandia’s heart related risk be added to the drug’s labeling.
In October, the group Public Citizen said it had identified 14 cases of Avandia-induced liver failure in the FDA’s Adverse Event Reporting System. Of the 14 cases of liver failure, 12 resulted in deaths. Those findings prompted Public Citizen to file a petition with the FDA asking that Avandia be removed from the market. The liver failure associated with Avandia, taken together with the drug’s risk of other side effects, including heart failure, fractures and vision loss, was too great to allow the drug to continue to be sold in U.S., the group’s petition said.
In October, the American Diabetes Association/European Association for the Study of Diabetes working group dropped Avandia from its treatment guidelines.