FDA Report – FDA Warning of Osteonecrosis of the Jawbone (ONJ)

Osteonecrosis of the Jaw (ONJ) in medical terms means dead (necrosis) and bone (osteo). This Fosamax warning was published in the Journal of Oral and Maxillofacial Surgeons, and it prompted the US Food and Drug Administration (FDA) and the manufacturer of Fosamax to issue a warning to health care professionals on September 24, 2004. Osteonecrosis of the Jaw (ONJ) is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The jawbone exposure can lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying jawbone. Medical experts say early detection and early treatment of patients with jaw bone necrosis is extremely important in preserving the jawbone.

Fosamax - Dead Jawbone Disease

ONJ or "dead jawbone disease" is a rare bone disease that can cause the patient's jaw bone to deteriorate and die. Since 2001, approximately 2,400 patients have reported ONJ. To repair jaw bone damage, a painful surgery is required to remove dying bone tissue. ONJ side effects include jaw pain, numbness, exposed oral bones, loss of teeth and infection. Fosamax and other bisphosphonate drugs have been used for over 10 years to treat osteoporosis and bone cancer by inhibiting bone resorption. These drugs are administered orally or intravenously. Other popular bisphosphonate drugs include Didronel, Aredia, Skelid, Actonel, Evista, Boniva, and Zometa.

Several other bisphosphonate drug manufacturers revised their warning labels to include the risk of jawbone or jaw tissue disease (ONJ). In 2005, in face of ther FDA reccomendations, Merck representatives said they would add information about ONJ to the Fosamax warning label.

Fosamax Injury Lawsuits

If you or a loved one have taken Fosamax and suffered from necrosis of the jawbone, Osteonecrosis of the Jaw (ONJ) or other jawbone problems or side effects, please use our online form or call us for a Free Confidential Fosamax Injury Evaluation. Call Toll Free 1-800-883-9858 for Fosamax Lawyer Help.