A dangerous connection between alendronate and ONJ

Alendronate (Fosamax®, Merck) is a widely-prescribed bisphosphonate used to treat osteoporosis and other bone diseases. The drug has been a top-seller for Merck for over a decade, earning the company billions of dollars each year.

In September of 2004, the Journal of Oral and Maxillofacial Surgeons issued a report which led to dramatic health care warnings by both the US Food and Drug Administration (FDA) and Fosamax’ manufacturer, Merck. The report warned of a dangerous connection between alendronate and osteonecrosis of the jaw (ONJ) or “dead jaw.”

ONJ is a devastating bone disease that affects both the mandible and maxilla jaw bones – causing both decay and death of the bone matter. Victims of ONJ have necrotic bone or bone marrow that has been starved by low blood flow. Even in mild forms, ONJ can create a bone marrow environment that’s extremely conducive to bacterial growth – worsening the effects of the disease.

One such case is David Tundell, a 61-year-old former aircraft maintenance officer in the Air Force and a plaintiff in a Fosamax lawsuit in Florida. Tundell took Fosamax for just one year to help with the osteoporosis in his hips. However, he alleges that his Fosamax use led him to a 3-day hospitalization last year when his jaw swelled so severely he could no longer eat. Doctors were forced to remove all of his teeth and shave part of his jaw to remove the dead bone.

Unfortunately, these stories are becoming more and more common, as are the lawsuits.

The most common side-effects of alendronate are:

    • Mild heartburn or stomach upset
    • Diarrhea, gas or constipation
    • Mild joint or back pain
    • Headache

Less common, but more severe side-effects are listed as:

    • Chest pain
    • Difficulty or pain when swallowing
    • Pain or burning under the ribs or in the back
    • New or worsening heartburn
    • Severe joint, bone or muscle pain
    • Jaw pain, numbness or swelling

Signs of possible ONJ are are:

    • Pain, swelling or infection of the gums
    • Loosening of teeth
    • Poor Healing of the gums
    • Numbness or the feeling of heaviness in the jaw
    • Partial or complete loss of the jaw bone

Free Consultation

If you believe your Fosamax use has put you or a loved one in danger, please fill out our Case Review Contact Form on this page to find out what your case is worth.