Fosamax® (alendronate) Investigation

Stueve Siegel Hanson is investigating Fosamax® as it relates to femur fractures and other side effects. Fosamax®, the brand name for the drug alendronate sodium, is a popular drug in the bisphosphonate class of medications and is prescribed for the treatment of osteoporosis. Fosamax is also approved for a variety of other indications, including other bone diseases such as Paget's disease. These drugs are also given to cancer patients for the prevention of fractures due to bone metastases.

The drug is purported to strengthen bones, however evidence has shown long-term use of Fosamax® or its generic equivalent alendronate has the opposite effect. Some women who are taking the drug have suffered from Osteonecrosis of the jaw (ONJ) and many women who have been taking the drug long-term have experienced atypical femur fractures during normal everyday activities.

Osteonecrosis of the of the jaw (ONJ) 

ONJ is caused by reduced blood flow to the jaw that studies suggest may be caused by bisphosphonate compounds like Fosamax. ONJ is a progressively debilitating condition that results in bone death, and often leads to serious complications including:

  • Jaw pain
  • Infection of the gums or jaw infection
  • Jaw swelling
  • Loosening of the teeth
  • Tooth ache
  • Poor healing gums
  • Numbness or a feeling of heaviness in the jaw (“Numb Jaw” or “Heavy Jaw”)
  • Exposed jawbone and drainage

ONJ is a painful, disfiguring bone disease that affects people’s jaw bones, specifically the bone mass in the mandible (lower jaw bone) and maxilla (upper jaw bone) die. Usually this is caused by a badly performed tooth extraction procedure that leaves a portion of jaw bone exposed. It then becomes infected and the jaw bone begins dying off. In extreme circumstances, the patient’s jaw bone must be removed to prevent further bone damage.

Femur Fractures

In 2008, the FDA pressured Merck about constant reports of femur fractures. After more than a year, Merck politely responded by adding femur fractures to the list of possible side effects of the drug. Nevertheless, these important concerns were never fully disclosed to the public or to doctors who continue prescribing the drug to combat the effects of osteoporosis.

Studies in the Journal of Orthopedic Trauma and the Journal of Bone and Mineral Research link Fosamax® to a rare type of spontaneous fracture in the femur. These studies looked at patients who experienced "low-energy" femur fractures, meaning that the bone fractures result without serious trauma. Fosamax fractures have reportedly developed when the patient was walking, ascending steps or participating in low-energy exercise. Fosamax leg fractures are said to be spontaneous in nature and atypical, as they develop in the long part of the thigh bone and the bone below the hip joint, which are not typically affected by osteoporotic fractures. In fact, the femur is one of the largest and strongest bones in the body. The results showed that patients taking Fosamax® on average for four years or more and those not taking Fosamax® had similar numbers of atypical subtrochanteric femur fractures mirroring classical osteoporotic hip fractures.

In 2010, the FDA began working with the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force to gather additional information that promised to provide insight into the risks associated with the drug. A study of more than 300 cases of femur fractures found that 94% of the patients had taken bisphosphonates, and most had been on the drugs for five years or more. The study also found that more than half of the patients studied experienced groin or thigh pain for a period of weeks or months before their fractures. As a result, updated FDA recommendations are now available for healthcare professionals as well as patients about the possible risks and side effects of oral bisphosphonates based on mounting results of clinical trials and ongoing studies. 

Since its introduction, Fosamax has been used by more than 20 million people around the world, generating billions of dollars in sales for its manufacturers and marketers. If you have experienced serious side effects noted above caused by Fosamax and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.

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