Fosamax (alendronate sodium) is a brand-name prescription drug manufactured by Merck that was first approved for use in the U.S. in 1995. Fosamax is in a class of medications called biphosphonates that increase bone density and prevent bone loss. It is used to prevent and treat osteoporosis in women who have gone through menopause, to treat osteoporosis in men, to treat osteoporosis in men and women who take corticosteroids, and to treat Paget’s disease, a condition that causes bones to be weak and soft that may become deformed.
During the Summer of 2011, the FDA notified healthcare professionals and patients that it was reviewing published studies to determine whether Fosamax and other oral biphosphonates increased the risk of esophageal cancer. Furthermore, there have been numerous lawsuits filed throughout the United States alleging that the use of Fosamax is associated with osteonecrosis of the jaw (“ONJ”) following invasive dental procedures or oral surgery. Merck’s “Warnings And Precautions” regarding Fosamax include, “For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.”
There is also attention being paid to the possible connection between the use of biphosphonates (such as Fosamax) and femur fractures (subtrochanteric and diaphyseal femoral stress fractures). The femur fractures may be atypical and subtle, and impending subtrochanteric femoral stress fractures may be misdiagnosed as trochanteric bursitis. In fact, Merck warns, “Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.”
If you may have been injured as a result of using Fosamax or another drug, you may be entitled to compensation for your injuries and losses. You should promptly contact a medical malpractice attorney (a drug claim attorney) to investigate your possible drug claim for you.
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