A new study has identified a causal link between the popular osteoporosis drug Fosamax (generic: alendronate) and nonhealing femur fractures. While Fosamax is designed to strengthen bones and reduce the risk of fractures associated with osteoporosis, long-term use of the drug has been increasingly linked to low-trauma femur fractures, where the bone breaks after little or no trauma at all. Merck, the company that manufactures and markets Fosamax, is currently facing about 3,000 lawsuits in courthouses around the country alleging that it failed to provide adequate warnings about the health risks associated with long-term use of the drug.
What’s the problem?
March 13, 2013 – The new research, which was published in last month’s edition of the Journal of Bone & Joint Surgery, looked at data from the FDA’s adverse event reporting database and found that nonhealing femur fractures are not just associated with Fosamax and other bisphosphonate medications, but directly caused by them. Specifically, the researchers identified a proportional reporting ratio of 4.51 between the use of Fosamax and other bisphosphonates and nonhealing femoral fractures. The majority of these injuries were seen in Fosamax users.
First approved in 1995, Fosamax is prescribed for the treatment and prevention of osteoporosis. Before its patent expired in 2008, at which time it became available as a generic, Fosamax was prescribed to millions of patients around the country and generated more than $3 billion in annual profits for Merck.
In October 2010, the FDA ordered Merck to update Fosamax warning labels to include information about the risk of bone fractures that had been associated with the drug. The new warnings included verbiage about the importance of identifying symptoms of new hip or groin pain, which can occur before an atypical femur fracture.