The findings of a recent 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.
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
What’s the problem?
The latest research, which appears in the Journal of Clinical Endocrinology & Metabolism, found that Avandia & Actos increased the risk of fractures in postmenopausal women with type-II diabetes, as well as in men prescribed either Avandia or Actos plus a loop diuretic.
The new study used data from a large study known as TRIAD, identifying 786 cases of fractures and comparing them to 2,657 patients who had diabetes but no fracture history. Of the 786 patients with fractures, only 54 were women less than 50 years old, while 457 were women 50 and older and 275 were men.
Women over 50 who had broken bones were 71 percent more likely to have been prescribed a thiazolidinedione. In men, the increased risk (more than triple) was seen among those taking both a thiazolidinedione and loop diuretics like Lasix, but not in just one or the other. The researchers pointed out that loop diuretics have been linked with bone density decreases. In both genders, the fracture risk went up the longer a person was on the medication.
According to the researchers, the fractures seen in the study weren’t just the spine and hip fractures most often seen in people with osteoporosis. Many of the people included in the study suffered lower limb, arm, and leg fractures.
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.