Patients who experienced a Fosamax fracture of the femur, hip, or thigh bone after taking the drug.
Fosamax has been linked to osteonecrosis of the jaw (dead jaw) and spontaneous femur fractures.
Fosamax treats osteoporosis in postmenopausal women.
The Fosamax label was updated to include the risk of dead jaw in July 2005 and the risk of femur fractures in October 2010.
In October 2010, the FDA updated the Fosamax warning label to highlight the risk of atypical thigh fractures in patients taking bisphosphonates for osteoporosis. Although the FDA has yet to establish a definite link between bisphosphonates and femur fractures, unusual bone fractures occurred predominately in those taking Fosamax, or a similar osteoporosis drug. In fact, a report from the American Society of Bone and Mineral Research revealed that more than 300 osteoporosis patients developed a rare femur fracture, and 94% of these individuals had been taking Fosamax or another bisphosphonate drug.
Fosamax and Femur Fractures
Femur fractures are described as “atypical” because they affect sites such as the long part of the thigh bone and the bone below the hip joint, which are infrequently affected by osteoporotic fractures. Atypical femoral fractures are said to be spontaneous in nature and occur without any real trauma or strenuous activity. For instance, thigh fractures may develop while performing simple activities, such as standing up or walking.
Researchers believe that Fosamax hinders the development of new collagen and causes microdamage in the bone, making patients more susceptible to these fractures. Specifically, the drug is said to harden the outer layer of bones cells, inhibiting the cells from being replenished through normal bone remodeling. Consequently, micro-fractures can accrue and may result in a serious femur fracture.
Jaw Problems: Osteonecrosis
Femur fractures were identified as a side effect of Fosamax after instances of osteonecrosis of the jaw were reported in users. Also known as dead jaw, osteonecrosis of the jaw (ONJ) occurs when bone tissue in the jaw cannot heal after minor dental work, such as tooth extraction, crown placements and root canals. Symptoms associated with osteonecrosis may include the following:
Loosening of the teeth
Numbness in the jaw
Dead jaw leaves the bone exposed, and may lead to infections, rotting and fractures. Some patients suffering from osteonecrosis may require surgery or lengthy antibiotic treatments. In some cases, osteonecrosis may be irreversible.
Patients who have developed a femur fracture, thigh fracture or osteonecrosis of the jaw may be able to participate in a class action lawsuit against the manufacturer of Fosamax to recover compensation. Drug manufacturers are required to ensure the safety of their products before releasing them into the marketplace, and failure to warn consumers about potential side effects may provide grounds for legal action.