Fosamax and Osteonecrosis

Fosamax is one of a class of drugs called bisphosphonates prescribed to prevent osteoporosis, reduce bone fractures, and increase bone density. Fosamax is manufactured by Merck & Company. Many serious side effects have been reported from the use of prescription and intravenously administered Fosamax. These include the following:

• Joint and bone pain
• Abdominal pain
• Nausea
• Acid reflux or regurgitation
• Osteonecrosis of the jaw (ONJ)
• Esophageal ulcers

The most serious side effect of the drug Fosamax is the link to cases of osteonecrosis of the jaw. By 2005, over one thousand cases of osteonecrosis of the jaw or jaw death had been reported among those patients who had taken the class of drugs called bisphosphonates including Fosamax. Osteonecrosis of the jaw was reported in women who had teeth extractions while taking the widely prescribed osteoporosis medication Fosamax. Thousands of women now take bisphosphonates to reduce the chance of bone loss as they age.

A study in the Journal of Endodontics states that due to the fact that so many women are prescribed bisphosphonates for bone loss, the numbers of patients who suffer from osteonecrosis of the jaw could grow into an epidemic. In a published report by Ken Hargreaves, DDS, PHD, two cases of osteonecrosis of the jaw in cancer patients on monthly doses of intravenous bisphosphonates were documented. Dr. Hargreaves says that it is clear from these and from other published cases that patients taking bisphosphonates should be warned that they may be at risk of developing osteonecrosis of the jaw if they have teeth pulled while taking medications such as Fosamax. Root canals should be performed on these patients—not tooth extractions. Researchers also note, however, that a significant number of cases of osteonecrosis of the jaw occurred, not after tooth extractions, but spontaneously. As of August of 2005, nearly 1,500 cases of osteonecrosis of the jaw had been reported among patients taking bisphosphonates. Researchers also have concluded that bisphosphonates in pill form do not appear to be as likely to cause osteonecrosis of the jaw as do intravenous versions of the drugs.

The Food and Drug Administration (FDA) has called on those companies who manufacture bisphosphonates to include on drug labels a warning about the risk of osteonecrosis of the jaw. Metabolization of these medications designed to reduce bone loss especially in cancer patients occurs slowly and the drug remains in the bone tissue for many years. Stopping treatment, therefore, does little good, and once osteonecrosis occurs, little can be done to reverse the condition.

Osteonecrosis of the jaw is a disabling and disfiguring condition in which the jaw bones literally die through rotting away and infection. The onset of osteonecrosis is linked to the temporary or permanent loss of blood to bone tissue which leads to the eventual death of the bone tissue and collapse of the bone. Over 10,000 cases of osteonecrosis of the jaw occur in the U.S. each year, most as the result of some type of injury to the bone such as fracture or dislocation, or due to the use of bisphosphonate drugs. Osteonecrosis occurs when the jaw fails to heal after suffering a minor trauma such as a tooth extraction which causes bone exposure. Causes of osteonecrosis include exposure to bisphosphonates used in cancer treatments and used to prevent bone loss (osteoporosis) such as Fosamax, Actonel, and Boniva. Some researchers have theorized that bisphosphonate medications can prevent the formation of new blood vessels within jawbone tissue. Because the jawbone cannot produce new blood vessels, the natural healing process of the bone is compromised and degradation of bone mass occurs. The earlier the condition of osteonecrosis is diagnosed, the more options a specialist will have to provide treatment. If osteonecrosis goes undetected and undiagnosed, however, it can result in irreversible bone collapse and disfigurement.

For the first months osteonecrosis of the jaw is usually asymptomatic, meaning without symptoms which would alert patients to the appearance of the condition. Symptoms may first appear only after minor trauma to the mouth occurs.

Osteonecrosis symptoms include the following:

• Gums that do not heal
• Dramatic gum loss
• Loosened teeth
• Swelling, pain and infection in the jaw or in the gums (The pain experienced may be similar to that which is suffered by victims of arthritis.)
• A feeling of heaviness in the jaw region
• Numbness of the jaw
• Exposed bone
• Drainage

If it is suspected that the patient is developing osteonecrosis of the jaw:

• Intraoral films may be used in order to demonstrate subtle changes in bone tissue and mass.
• Panoramic or tomographic imaging may be done in order to eliminate the possibility of other causes of symptoms such as impacted teeth or cysts.
• Microbial cultures can be used for diagnosis of oral infections present.
• Tissue biopsy should be performed infrequently and only if the disease is suspected to have metastasized because trauma induced by performing the biopsy could result in additional complications from the disease.

Below is a listing of all oral and intravenously administered bisphosphonates which are currently on the U.S. market and which may contribute to the development of the condition osteonecrosis of the jaw.

Bisphosphonates administered orally:

• Actonel, manufactured by Proctor & Gamble Pharmaceuticals—generic name risedronate
• Boniva, manufactured by Roche Laboratories—generic name ibandronate
• Fosamax, manufactured by Merck & Company—generic name alendronate
• Fosamax Plus D, manufactured by Merck & Company—generic name alendronate
• Skelid, manufactured by Sanofi Pharmaceuticals—generic name tiludronate
• Didronel, manufactured by Proctor & Gamble Pharmaceuticals—generic name etidronate

Bisphosphonates administered intravenously:

• Aredia, manufactured by Novartis—generic name pamidronate
• Zometa, manufactured by Novartis—generic name zolendronic acid
• Bonefos, manufactured by Schering AG—generic name clodronate

If you or a loved one has experienced side effects from Fosamax, contact the New York attorneys at Schwartzapfel Partners, P.C.

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These Hubs are provided for informational purposes only and should not be considered legal advice. Professional legal counsel should be sought for specific advice relevant to your circumstances.