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 achievable risk of atypical thigh bone (femur) fractures in patients who take bisphosphonates, such as Fosamax.  Bisphosphonates are a class of drugs used to prevent and treat osteoporosis. Atypical femur fractures, a rare but severe kind 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.
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 employed lengthy-term for osteoporosis therapy.&rdquo &ldquoIn the interim, it&rsquos critical for patients and well being care professionals to have all the safety data readily available when determining the ideal 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 review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all available data on bisphosphonate use, such as information summarized in the American Society for Bone Mineral Research Activity Force report. The report proposed additional item labeling, greater identification and tracking of patients experiencing these breaks, and more investigation to determine no matter whether and how these drugs lead to the severe but uncommon fractures.

Based on the FDA&rsquos review, the Warnings and Precautions section of all bisphosphonate goods for osteoporosis, such as Fosamax, will be revised to include the femur fracture warning, and the FDA will require the inclusion of the identical femur fracture warning into a Medication Guide to better inform patients of the doable increased fracture danger. People who have suffered a femur fracture after taking Fosamax may want to file a fosamax lawsuit.

Given this most current femur fracture warning, the FDA recommends that well being care experts be aware of the achievable 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 5 years.

Patients taking bisphosphonates must report any new thigh or groin discomfort 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.

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