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Fosamax® Jawbone Loss

Fosamax® (alendronate) is a medication taken by persons who have or are at risk of having osteoporosis, a condition of thinning and weakened bones. The drug is in a class of medications known as biophosphonates.

Dead jaw or osteonecrosis of the jaw (ONJ) is a condition in which the tissue of the jawbone is deteriorating and dying. A link has been made between taking Fosamax® and the occurrence of ONJ. Most often, this occurs in cancer patients who have received intravenous injections of Fosamax®, but instances of patients taking Fosamax® orally also have occurred.

The main symptoms of ONJ include:

Severe pain
Swelling
Infection of jaw tissue
Drainage
Loosening of the teeth

People taking Fosamax® who are at increased risk of ONJ have had:

Invasive dental procedures such as tooth extraction, dental implants or bone surgery
Cancer treatment therapies, including chemotherapy, radiation therapy and corticosteroids
Poor dental hygiene
Other disease such as disease of the gums or other dental disease, anemia, problems with blood clotting, infection, poorly fitting dentures

Merck & Co., the drug’s manufacturer reports that in controlled clinical trials in which more than 17,000 patients participated and were treated with Fosamax®, there were no instances of ONJ. Since Fosamax® and Fosamax® Plus D were introduced to the market more than 225 million prescriptions have been prescribed, Merck said. The company said that by Jan. 15, 2009, the rate of ONJ ranged between 1.6/100,000 patient treatment years and .384/100,000 patient-treatment years.

Some research reports do not agree with these statistics and their data show a much greater incidence of ONJ among bisphosphonate patients. An article in the October 2007 issue of Community Oncology suggests there is a need for more accurate and vigilant record keeping regarding the occurrence and causes of the disorder.

However, the package insert with Fosamax® or Fosamax® D states that “Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking biophosphonates, including Fosamax ® [Fosamax® D].”

The package label goes on to say that patients taking biophosphonates and planning to have dental surgery might reduce their risk of ONJ if they discontinue taking the biophosphonates.

Osteoporosis is the most common bone disease in the country. It can lead to bone loss and fractures. More than 10 million Americans 50 years old and over have osteoporosis. About 34 million have low-density bones, a pre-osteoporosis condition. Our bones are continuously turning over bone tissue, allowing old bone tissue to die and replacing it with new tissue. Osteoporosis occurs when the rate of bone loss exceeds the rate of bone replacement.

Permanent Damage from Fosamax®

Osteonecrosis of the jaw leads to permanent damage of the face. The jaw area is disfigured where tissue has died or becomes infected. The approach to each patient must be individualized and depends upon the amount of jawbone damage and death.

If you’ve suffered jawbone loss, you may be eligible to seek compensation for the damages incurred and the challenges ahead. For more information about your legal options, please contact our Fosamax® lawyers for help. We will evaluate your specific circumstances to determine a legal strategy that suits your needs.

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