The findings of a new study add to the increasing body of evidence linking side effects of the diabetes drugs Actos and Avandia to an increased risk of bone fractures.
According to new research published this month in the Journal of Clinical Endocrinology and Metabolism, older women taking Actos or Avandia were found to have a higher rate of bone fractures. Researchers found that the use of Avandia and Actos was far more common among women 50 and older who had suffered fractures than those who had not had bone fractures. They also found that the women taking the diabetes drugs were 50% more likely to have limited mobility.
Researchers found no link between the drugs and fractures in women under 50, suggesting that the effects seem to be limited to post-menopausal women. Among men, the drugs only seemed to increase the risk of fractures for those who were also taking a loop diuretic, like Lasix or Bumex.
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 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 health risks appear to outweight the benefits provided by the medication. Other side effects of Avandia could include an increased 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 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. The FDA is currently considering whether to cancel clinical trials on Avandia heart problems, which some critics say would be unethical to continue.
GlaxoSmithKline has recently settled about 10,000 out of an estimated 13,000 Avandia lawsuits filed by former users of the drug who allege that the drug maker failed to adequately research their medication or warn users about the serious side effects.