Drug & Device Lawsuit
Recent Data on Fosamax Femur Fracture Latest FDA Warnings?
The U.S. Food and Drug Administration (FDA) on October 13, 2010, came up with a femur fracture warning that informs patients and health care professionals on possible risks pertaining to atypical thighbone (femur) fractures in patients who are under bisphosphonates, such as Fosamax, medication. Bisphosphonate is a drug classification that is used for the prevention and treatment of osteoporosis. Atypical Fosamax femur fractures, a rare but serious condition of the thighbone, have been reportedly prevalent in patients under biophophanate, such as Fosamax, medication for longer than five years.
A most recent femur fracture warning by the FDA appears in the labeling change and Medication Guide for Fosamax, Fosamax Plus D, as well as their generic counterparts.
In regard to this femur fracture warning, the FDA says that the agency is “continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment.” The statement further say that “In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”
The ongoing femur fracture warning follows a Drug Safety Communication dated March 10, 2010 that announces the FDA’s current safety review of bisphosphonate use and the occurrence of atypical femur fractures among its users. The FDA has so far reviewed all available information on bisphosphonate use. The summation includes data summarized in the report released by American Society for Bone Mineral Research Task Force. The report recommends further product labeling, better identification and tracking of patients experiencing these femur fractures, and further research to assess whether and how these drugs correlates to the serious, yet uncommon, fractures.
Based on the FDA’s review, the Warnings and Precautions section of all bisphosphonate products for osteoporosis, including Fosamax, will be revised to include the femur fracture warning, and the FDA will require the inclusion of the same femur fracture warning into a Medication Guide to better inform patients of the possible increased fracture risk.
With this latest femur fracture warning, the FDA is recommending that health care providers be updated on the possible risks patients are faced in taking bisphosphonates and consider regular reevaluation of the necessity for continued bisphosphonate treatment for patients who have been on bisphosphonates for longer than five years.
