How should you evaluate a potential Fosamax case?
The length of time a person took Fosomax is likely the most important factor in determining whether a person has a claim. The magic number is five years. This number comes from an FDA warning issued on October 13, 2010 to patients and health care providers about the possible risk of atypical thighbone (femoral) fracture in patients who take bisphosphonates. According to the FDA warning, the optimal use of bisphosphonates use for osteoporosis is unknown and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years. Furthermore, the FDA recommends that health care providers consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.
Why five years? While there is no doubt that use of Fosomax increases bone density that however “does not necessarily equate with good bone quality.” The problem is that “turnover is a natural part of maintaining bone health.” The use of Fosomax however reduces osteoclast activity and bone resorption. As a result, bone formation is also reduced, thus over a long period of time microdamage, that naturally occurs in bones, that would otherwise be normally repaired by the body, begins to accumulate.
What is also significant is that merely ceasing to take Fosomax or its generics, does not remove a person from the adverse effects of Fosomax. To the contrary, biphosphates, such as Fosomax, are stored in a person bones for up to ten years. In effect, early studies indicated that alendronate accumulates in the bone and re-circulates when bone containing the alendronate is remodeled. In fact, this quality was originally touted as one of the possible benefits of alendronate because “many years of treatment may produce self-sustaining concentrations.” (Study funded by Merck). Interestingly, this very same article published in 1998 noted that while the effects of alendronate may continue after a person has stopped treatment, “if alendronate were to cause an adverse effect that has not yet been recognized, endogenous exposure to alendronate would also continue after stopping treatment.” Thus, Merck clearly knew as of 1998 that absent studies of the long term effects of alendronate, Merck would essentially be gambling by continuing to manufacture and distribute Fosomax.
Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.
