Fosamax, the popular drug used by millions of women to treat osteoporosis, has been linked by several major studies to the occurrence of atypical femur (thigh bone) fractures. The preponderance of evidence associating Fosamax with the injury, which can occur following little or no trauma, has prompted the Food and Drug Administration (FDA) to strengthen the drug’s warning labels and, more recently, to question whether the drugs should be used long-term by osteoporosis patients.
Studies Linking Fosamax to Low-Impact Femur Fractures
The association between Fosamax and thighbone breaks has gained momentum since 2008, when a study appearing in the Journal of Orthopedic Trauma found that among 70 patients with a femur fracture, 25 (36 percent) were being treated with Fosamax. The researchers further detected a fracture pattern specific to long-term Fosamax use, which they posited was the result of the drug’s suppression of natural bone metabolism.
Two years later, a 2010 study published in the Journal of Bone and Mineral Research strengthened the suspicion that long-term Fosamax use can cause atypical femur fractures. According to data supplied by an American Society for Bone and Mineral Research (ASMBR) task force, 94 percent (291 of 310) of patients with a serious fracture of the thigh bone had been taking a bisphosphonate drug like Fosamax. Most of them had been taking the drugs for more than 5 years.
The FDA’s Stance on Bisphosphonates and Femur Fractures
The ASMBR findings led directly to a decision by the FDA to update bisphosphonate drug labels to include a warning about the risk of thigh bone fractures. The October 2010 warning specifically noted that while the optimum duration of bisphosphonate use for osteoporosis was unknown, use of the drugs for more than five years may be related to the fractures.
And the strongest evidence yet that extended use of Fosamax can lead to femur fractures comes from the FDA itself, in an analysis published online in the New England Journal of Medicine (NEJM) in May 2012.
The analysis, performed by the FDA in response to growing concern about the long-term safety and efficacy of bisphosphonates, found that beyond five years, the drugs show little if any benefit. In fact, the author of a companion piece to the FDA analysis said that “I think that a lot of people are going to come off this drug.”
RLG Offering Free Lawsuit Reviews
Just as you should not make the decision to stop taking Fosamax without first discussing the matter with your doctor, you should speak with a lawyer if you are considering a lawsuit against Merck & Co. for your femur break. To discuss the feasibility of litigation, and how much compensation you might be owed, contact the experienced lawyers of the Rottenstein Law Group by completing this online form on the right or calling 1-877-332-2347.
Learn More: Download RLG’s Free Fosamax Brochure