
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 used to stop and treat osteoporosis. Atypical femur fractures, a rare but significant sort of thigh bone fracture, have been predominantly reported in patients taking drugs such as Fosamax for longer than five years.
A labeling change and Medication Guide for Fosamax, Fosamax Plus D, and their generic items will reflect this most recent femur fracture warning by the FDA.
Research Assistance 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 therapy.&rdquo &ldquoIn the interim, it&rsquos crucial for patients and wellness care professionals to have all the safety details accessible when figuring out the very best course of therapy for osteoporosis.&rdquo
Today&rsquos femur fracture warning follows a March 10, 2010 Drug Safety Communication announcing the FDA&rsquos ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all accessible information on bisphosphonate use, which includes data summarized in the American Society for Bone Mineral Analysis Task Force report. The report recommended extra product labeling, greater identification and tracking of patients experiencing these breaks, and much more analysis to establish whether and how these drugs cause the serious but uncommon fractures.
Based on the FDA&rsquos evaluation, the Warnings and Precautions section of all bisphosphonate merchandise for osteoporosis, such as Fosamax, will be revised to incorporate the femur fracture warning, and the FDA will call for the inclusion of the very same femur fracture warning into a Medication Guide to greater inform patients of the possible increased fracture danger. People who have suffered a femur fracture after taking Fosamax may want to file a fosamax lawsuit.
Given this newest femur fracture warning, the FDA recommends that health care professionals be conscious of the doable risk in patients taking bisphosphonates and consider periodic reevaluation of the require for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.
Patients taking bisphosphonates must report any new thigh or groin discomfort to their health care provider and be evaluated for a doable femur fracture. If you or someone you know have suffered a femur fracture after taking Fosamax contact a fosamax lawyer for help.