On October 13, 2010, the U.S. Food and Drug Administration (FDA) issued a femur fracture warning informing patients and well being care providers about the possible risk of atypical thigh bone (femur) fractures in patients who take bisphosphonates, such as Fosamax. Bisphosphonates are a class of drugs utilized to stop and treat osteoporosis. Atypical femur fractures, a rare but significant kind of thigh bone fracture, have been predominantly reported in patients taking drugs such as Fosamax for longer than 5 years.
A labeling adjust and Medication Guide for Fosamax, Fosamax Plus D, and their generic products will reflect this latest femur fracture warning by the FDA.
Studies Support Femur Fracture Warning
With regard to this femur fracture warning, the FDA stated that it is &ldquocontinuing to evaluate information about the safety and effectiveness of bisphosphonates when utilized long-term for osteoporosis remedy.&rdquo &ldquoIn the interim, it&rsquos important for patients and health care pros to have all the safety data available when figuring out the greatest course of therapy for osteoporosis.&rdquo
These days&rsquos femur fracture warning follows a March ten, 2010 Drug Safety Communication announcing the FDA&rsquos ongoing safety evaluation of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has because reviewed all available data on bisphosphonate use, which includes information summarized in the American Society for Bone Mineral Research Job Force report. The report suggested extra item labeling, much better identification and tracking of patients experiencing these breaks, and far more analysis to decide regardless of whether and how these drugs cause the significant but uncommon fractures.
Based on the FDA&rsquos evaluation, the Warnings and Precautions section of all bisphosphonate products for osteoporosis, which includes Fosamax, will be revised to incorporate the femur fracture warning, and the FDA will need the inclusion of the very same femur fracture warning into a Medication Guide to better inform patients of the doable improved fracture threat. People who have suffered a femur fracture after taking Fosamax may want to file a fosamax lawsuit.
Given this latest femur fracture warning, the FDA recommends that wellness care professionals be aware of the feasible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than 5 years.
Patients taking bisphosphonates ought to report any new thigh or groin pain to their wellness care provider and be evaluated for a achievable femur fracture. If you or someone you know have suffered a femur fracture after taking Fosamax contact a fosamax lawyer for help.