Tuesday 7th February 2012
by admin
On October 13, 2010, the U.S. Food and Drug Administration (FDA) issued a femur fracture warning informing patients and wellness care providers about the possible threat of atypical thigh bone (femur) fractures in patients who take bisphosphonates, such as Fosamax. Bisphosphonates are a class of drugs utilized to avoid and treat osteoporosis. Atypical femur fractures, a rare but significant type 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 goods will reflect this latest femur fracture warning by the FDA.
Scientific studies Help 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 used extended-term for osteoporosis remedy.&rdquo &ldquoIn the interim, it&rsquos critical for patients and well being care experts to have all the safety data accessible when determining the best course of remedy for osteoporosis.&rdquo
Right now&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 given that reviewed all readily available information on bisphosphonate use, which includes information summarized in the American Society for Bone Mineral Investigation Task Force report. The report suggested additional product labeling, greater identification and tracking of patients experiencing these breaks, and a lot more research to establish whether or not and how these drugs result in the serious but uncommon fractures.
Based on the FDA&rsquos evaluation, the Warnings and Precautions section of all bisphosphonate items for osteoporosis, including Fosamax, will be revised to consist of the femur fracture warning, and the FDA will demand the inclusion of the identical femur fracture warning into a Medication Guide to far better inform patients of the feasible elevated fracture threat. 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 well being care pros be aware of the feasible threat in patients taking bisphosphonates and contemplate periodic reevaluation of the require for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than 5 years.
Patients taking bisphosphonates should report any new thigh or groin pain to their health care provider and be evaluated for a possible femur fracture. If you or someone you know have suffered a femur fracture after taking Fosamax contact a fosamax lawyer for help.
Tags: fosamax lawsuit, fosamax lawyers