Merck & Co., Inc. discovered alendronate sodium more than twenty years ago and found that it could treat bone diseases like osteoporosis and Paget’s disease by preventing people’s bones from degenerating, a process called “resorption.” After naming it “Fosamax,” Merck received approval from the U.S. Food & Drug Administration (FDA) to sell the drug in 1995, though its patent would expire in 2008. Fosamax was a highly successful drug and before its patent expired Merck sold three billion dollars worth of Fosamax in 2007. By then doctors had prescribed it twenty million times.
Recently, medical experts have connected Fosamax to atypical femur (thigh bone) fractures. These fractures are unusual for a few reasons. First, they are low-energy or low-impact injuries, meaning the person either fell from standing height or was just standing with then break occurred. Normally, femurs, one of the largest and strongest bones in the human body, do not break under such slight or non-existent stress. Second, the fractures are unusual because they are horizontal, which is not what orthopedists would predict from those kinds of falls. As reports began appearing, medical experts began researching the issue.
Two studies have shed light on the atypical femur fractures. The first appeared in the Journal of the American Medical Association (JAMA) in its February 2011 issue. In that study, doctors surveyed 200,000 long-term female bisphosphonate users over 68. The authors determined that Fosamax users are three times as likely to suffer a bone break after using the drug for a five-year period because bisphosphonates make bones brittle as it hardens them.
The second study, published on May 5, 2011 in the New England Journal of Medicine (NEJM), reinforces these findings. This new study, conducted in Sweden, surveyed 12,777 women over the age of 58 who suffered any kind of femur fracture in 2008. The researchers then narrowed their focus to only those whose fractures resembled the atypical ones reported by bisphosphonate users. Of that group, 78% had been taking bisphosphonates as opposed to only 10% of the control group, whose injuries were typical. The study showed that Fosamax use increased the likelihood of an atypical bone break by 47.3 times. Fortunately, ceasing use or going on a drug holiday reduced the risk of a bone break by 70% per year since the last use.
The U.S. Food and Drug Administration (FDA) has moved slowly on this matter. On the one hand, it did release a Fosamax safety warning in March 2010 and required a label change in October 2010. On the other hand, on March 10, 2011, it issued a Fosamax safety announcement claiming it couldn’t find a clear connection between Fosamax and femur fractures. This announcement was based on research prior to the JAMA and NEJM studies. Merck vigorously opposed both studies.
If you’ve suffered injury after using Fosamax, and it occurred from standing height or less, our fosamax lawyers wants to hear about it. For a free, confidential legal consultation, click on this link.