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 doable danger of atypical thigh bone (femur) fractures in patients who take bisphosphonates, such as Fosamax. Bisphosphonates are a class of drugs employed to prevent and treat osteoporosis. Atypical femur fractures, a rare but serious type 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 items will reflect this most current femur fracture warning by the FDA.
Studies Assistance Femur Fracture Warning
With regard to this femur fracture warning, the FDA stated that it is &ldquocontinuing to evaluate data about the safety and effectiveness of bisphosphonates when employed long-term for osteoporosis treatment.&rdquo &ldquoIn the interim, it&rsquos crucial for patients and wellness care specialists to have all the safety details readily available when determining the best course of treatment for osteoporosis.&rdquo
Today&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 considering that reviewed all accessible information on bisphosphonate use, including information summarized in the American Society for Bone Mineral Investigation Process Force report. The report recommended extra product labeling, better identification and tracking of patients experiencing these breaks, and a lot more study to decide no matter whether and how these drugs result in the critical but uncommon fractures.
Based on the FDA&rsquos assessment, the Warnings and Precautions section of all bisphosphonate merchandise for osteoporosis, including Fosamax, will be revised to contain the femur fracture warning, and the FDA will need the inclusion of the same femur fracture warning into a Medication Guide to far better inform patients of the feasible elevated fracture risk. 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 experts be conscious of the feasible danger in patients taking bisphosphonates and think about periodic reevaluation of the want for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.
Patients taking bisphosphonates really should report any new thigh or groin discomfort to their well being 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.