Fosamax and Osteonecrosis of the Jaw (ONJ)

At its 2006 annual meeting, the American Association of Endodontists declared that, until further information becomes available, all patients taking bisphosphonates, such as Fosamax, are considered at risk of developing osteonecrosis of the jaw (ONJ). Also known as avascular necrosis of the jaw, aseptic bone necrosis of the jaw, and oral osteonecrosis, ONJ is a serious, irreversible, and disfiguring bone condition. The name literally means "jaw bone death", and is the result of loss of the blood supply to the jaw. The condition can lead to serious complications, including ulcerations within the lining of the mouth, infection, and breakdown of the jawbone. Although ONJ is not life threatening, it can become extremely debilitating. ONJ is believed to be an extremely rare condition. Clinical studies performed since Fosamax's approval by the FDA have linked ONJ to oral bisphosphonate therapies, such as Merck's osteoporosis drug, Fosamax.

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How Fosamax causes loss of blood flow to the jaw remains unclear, but research is currently being performed in hopes of pinpointing the precise mechanism. Experts do, however, have an understanding of ONJ itself and how the condition progresses. ONJ occurs when bone loses its ability to regenerate (remodel) once blood is hindered from flowing through or reaching the bone. Although bone may seem like a dense mass of calcium and other minerals, it is actually a living vascular organ containing a number of channels (called, Haversian canals) through which blood flows. These blood vessels continuously carry minerals, such as calcium, from other areas of the body and deposit them in the bone tissue where they are used to build new bone. Concurrently, the blood vessels carry minerals out of aged or damaged bone (such as the area of a bone fracture) so that the area can be remodeled with healthy new bone. If blood vessels flowing to the bone become blocked, the bone will not receive or be able to exude the required minerals for remodeling. If the process of bone remodeling ceases, the existing bone tissue will die and eventually rot. The dead and rotting bone is referred to as necrotic and cannot be brought back to life. Along with the hips and knees, the jaw bone is especially susceptible to reduced blood flow problems, and is therefore more susceptible to developing osteonecrosis than other parts of the body.

Typically, those who develop ONJ do not exhibit symptoms until months or years after the jaw bone dies. In most cases, symptoms do not appear until soft-tissue in the mouth begins to ulcerate and, unable to heal, causes the necrotic bone beneath the gums to become exposed. The ulceration of the soft-tissue, usually occurs as the result of an infection of the underlying rotted bone. Once bone is dead, it loses immune ability, becoming unable to ward off infections. Also, if an infection develops in a patient's mouth or surrounding tissue, the infection tends not to heal. Although most dentists and oral surgeons prescribe a regiment of antibiotics along with a warm water or antiseptic mouth rinse to treat an infection, if the infection eventually heals, it is frequently a prolonged process and the treatment will not reverse ONJ itself.

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The same reasoning may apply to why dentists and oral surgeons often diagnose ONJ only after invasive procedures, such as tooth extractions. If the oral tissue is otherwise healthy, what would otherwise be only temporary damage done to the tissue during oral surgery or extraction will normally fail to heal in patients with ONJ. In fact, a study performed by the University of Miami School of Medicine concluded that the leading precipitous event that led to bone exposure in patients with ONJ was tooth extraction. Tooth extraction accounted for 37.8% of initial jaw bone exposure, with periodontitus accounting for another 28.6% of exposure, and periodontal surgery facilitating bone exposure in 11.2% of the patients studied. The same study concluded that the average time for bone exposure to occur spontaneously in Fosamax users is three years.

The most common way for ONJ to be diagnosed prior to becoming symptomatic is through the use of x-rays. X-rays are able to display a variation of calcium salts in a bone once the concentration of calcium salts decreases below 50% of its normal level. Although an x-ray of the jaw cannot prevent osteonecrosis from occurring, its assistance in diagnosing ONJ may help dentists and their patients prevent infections that could cause ulcerations and bone exposure.

Typical signs and symptoms of ONJ include jaw pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone. There is no cure for ONJ, and in most cases patients will eventually need to undergo surgical removal of portions of their decaying jaw bone. Patients with ONJ have found it difficult to chew solid foods, have complained of loss of feeling in their jaws, and have suffered from chronic pain.

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Dr. Robert E. Marx, who led the University of Miami's study on ONJ, has noted "complete prevention of this complication is not currently possible." Neither is a cure. It is widely believed in the orthopedic community that stopping osteoporosis treatment with Fosamax will do little good once the jaw bone dies. With over a thousand cases of bisphosphonate-associated ONJ diagnosed in the past three years, numerous more are expected to appear in the near future due to Fosamax's ability to remain active in the body for up to ten years after its user stops taking the drug.

If you or a relative have taken Fosamax and have been diagnosed with osteonecrosis of the jaw or experienced other adverse side effects, lawyers experienced in pharmaceutical injury litigation can provide you with more information regarding your rights. If you would like an experienced member of Seeger Weiss's legal staff to contact you, please fill out this short form. The firm maintains offices in New York City and New Jersey, and its attorneys handle cases nationwide.