Fosamax & Osteonecrosis of the Jaw (ONJ)

In recent years, bisphosphonates such as Fosamax have been tied to a medical condition called Osteonecrosis of the Jaw (ONJ), an extremely painful and disfiguring jaw bone disease that causes the jaw bone to decay and die, making it difficult to eat or even speak. Thus, while Fosamax is designed to help prevent and treat bone loss, Fosamax ironically can cause jaw bone loss.

Most cases of ONJ develop after some minor mouth trauma, such as a tooth extraction, which causes the jaw bone to be exposed. In such cases, jaw bone infection and fracture can occur, sometimes requiring long-term antibiotic treatment or surgery to remove the dead and dying bone tissue. Alarmingly, ONJ can develop years after a person stops taking Fosamax.

Common ONJ signs and symptoms can include:

loose teeth
exposed bone
jaw numbness
dramatic gum loss
jaw or gum pain, swelling, or infection

Because ONJ is irreversible, it is imperative that Fosamax patients prevent or get diagnosed with ONJ in its early stages. According to medical experts, early treatment for ONJ is extremely important in preserving the jawbone. Consequently, Fosamax patients displaying any of the above symptoms should consult a physician immediately.

Fosamax Warning

A relation between Fosamax and ONJ was first reported in an article published by the Journal of Oral and Maxillofacial Surgeons, which discussed the results of a study conducted on 63 patients being treated for ONJ. The study revealed that approximately 10% of the patients suffering from ONJ were also taking Fosamax.

This startling discovery prompted the FDA to look further into the link between Fosamax and ONJ. After an investigation, the FDA requested that Merck include a new warning on the Fosamax label to warn patients that Fosamax may cause jaw bone decay, also known as ONJ.

However, Merck did not comply with the FDA’s request to update the Fosamax warning label until almost a year later, in July of 2005. In addition to asking Merck to update the Fosamax warning label, the FDA has sent several letters to Merck criticizing the company for overstating the benefits of Fosamax and for underemphasizing the health risks associated with the drug’s use.

If you have developed Osteonecrosis of the Jaw (ONJ) as a result of taking Fosamax, you may be entitled to compensation. Please contact our experienced lawyers today to help you understand your rights.