Washington, DCThe US Food and Drug Administration (FDA) has updated its warnings concerning Fosamax side effects. Specifically, the FDA is concerned about the link between the use of Fosamax (known generically as alendronate sodium) and femur fracture. Although the FDA's warning does not mention Fosamax osteonecrosis of the jaw, it does discuss the risk of femur fracture in patients who use bisphosphonates—a class of drug that includes Fosamax.
The FDA's updated warning, issued in January 2011, notes that bisphosphonates have been linked to atypical fractures of the femur. Although the drugs have not been proven to directly cause the fractures, the fractures are mainly reported in patients who took bisphosphonates.
Based on this information, the FDA recommends that healthcare professionals periodically re-evaluate whether continued bisphosphonate therapy is needed, especially when the patient in question has been on the medication for more than five years; rule out a femoral fracture if the patient shows evidence of new thigh or groin pain; discontinue bisphosphonates if patients have evidence of femoral fracture; and discuss the benefits and risks of bisphosphonates.
Patients who experience groin or thigh pain of a dull or aching nature are encouraged to seek medical attention. Such pain can be a precursor to complete fracture and may appear months before the complete fracture occurs.
Along with Fosamax, drugs in the bisphosphonate class include Actonel (known generically as risedronate sodium), Boniva (known generically as ibandronate sodium), Atelvia (known generically as risedronate sodium) and Reclast (known generically as zoledronic acid).
Ironically, bisphosphonates are used to strengthen a patient's bone density but may be linked to an increased risk of femur fracture. The patients do not have to be involved in athletic activity when the fracture occurs. According to some reports, women who were simply walking down the street experienced a fracture.
The label on Fosamax and other bisphosphonates will be updated to reflect the new information from the FDA.
Bisphosphonates such as Fosamax have also reportedly been linked to an increased risk of osteonecrosis of the jaw, a serious condition in which the patient's jaw bone does not properly heal after minor traumas, tooth extractions or surgery, causing lost teeth and gum infections. Lawsuits have been filed against Merck, manufacturer of Fosamax, alleging the drug caused jaw bone damage.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Fosamax claim at no cost or obligation.