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
No comments:
Post a Comment