More Evidence Linking Fosamax to Bone Fractures

The New England Journal of Medicine has recently published a study which showed that the safety in the long term use of bisphosphonate drugs, like Fosamax, for osteoporosis treatment may be in question.The study suggested that in two separate case theories there has been a link between prolonged bisphosphonate therapy and atypical fractures.There was one study which showed a number patients sustained low-energy non-vertebral fractures while receiving long-term alendronate therapy; three were fractures of the femoral shaft.

Also the study showed that bone biopsies in the patients showed evidence of severely suppressed bone turnover and fracture healing that was delayed or not there at all.Fosamax is actually suppress bone turnover and thus might be associated with accumulated micro-damage in bone in theory.

In the published study the editor states: “To our knowledge, no study has demonstrated microdamage accumulation in patients treated with bisphosphonates, and data from studies in animals remain difficult to interpret because supranormal doses of bisphosphonates are used. Nevertheless, the possibility that bisphosphonates alter bone strength with prolonged use appears to exist.”

The length of Fosamax use seems to be a factor that the study takes into account.The results of the study concluded that the patients who have been on Fosamax for an average time longer than five years were 37% more likely to suffer from atypical fractures than patients who have been on the drug for less time

Fosamax lawsuit plaintiffs may want to take notice of the results of this this study as it may provide the link between Fosamax and bone fractures they have been looking for.As Merck and the FDA has both gone on record stating that more information is needed to link Fosamax to these types of bone fractures.

However the conclusion of the researchers have also stated that they need more information to definitely link Fosamax to atypical bone fractures.In conclusion the editor of the study states: “In light of the limitations of our study, a prospective study is indicated. Although many possible explanations exist, patients with the unique radiographic pattern shown here may represent a subgroup of the population that is more susceptible to the effects of prolonged suppression of bone turnover. Additional studies are needed to characterize this subgroup and to establish a clear association between atypical fractures of the femur and prolonged bisphosphonate treatment.”

URL References:

nejm.org/doi/full/10.1056/NEJMc0707493

health.usnews.com/usnews/health/healthday/080319/fosamax-linked-to-unusual-femur-fractures.htm

Fosamax Warning Labels Changed on Back of Online Publications

The United States Food and Drug Administration (FDA) recently updated its public information which it had previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures also commonly known as Fosamax femur fractures, in patients who take Fosamax for osteoporosis.All of the information which was made public will also be added to the Warnings and Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis.

There was also a recent new task force which reported on all bisphosphonates, just like Fosamax, and an association with atypical femur fractures in osteoporosis patients has caused the FDA to reconsider requiring drug companies like Merck to make a label change to increase the warning about this rare but serious side effect.

On September 14, 2010 the Journal of Bone and Mineral Research published and online article titled "Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the American Society for Bone and Mineral Research".In summary, the task force reviewed 310 cases of "atypical or low-impact femur fractures," and found that 94 percent (291) of patients had taken Fosamax, for more than five years.

Similarly another online article also published on September 14, 2010 titled "FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosphonates Use", states that the FDA may want to urge companies like Merck to change the warning labels on drugs like Fosamax.

This article made many physicians who would prescribe their patients Fosamax able to advise about the possibility of atypical femoral fractures and of the potential for bilaterality through a change in labeling of Fosamax.

Fosamax is a drug designed to help with bone loss due to several diseases like osteoporosis.However, the recent findings of several online publications have shown that Fosamax can actually cause atypical femur fractures.These findings of both the online publications and the task force has led the FDA to call for a change in the warning labels on Fosamax.To those who have suffered a low-impact bone fracture that has been caused by Fosamax use a consultation with a healthcare professional should be done as soon as possible.

URL References:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm
http://www.nejm.org/doi/full/10.1056/NEJMc0707493