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Dr. Eric Hanson | 2820 NW 32nd St. | Newcastle, OK The Food and Drug Administration and Novartis Pharmaceuticals Corporation have each issued a drug precaution for health professionals regarding a condition known as Osteonecrosis of the Jaw (ONJ). According to these precautions, this condition has been observed in cancer patients who undergo invasive dental procedures such as dental implants or tooth extractions while receiving treatment with intravenous bisphosphonates. ONJ can cause severe, irreversible, and often debilitating damage to the jaw. The two intravenous bisphosphonates that were mentioned in the precautions are marketed by Novartis under the trade names Aredia and Zometa. Bisphosphonates, also known as bone-sparing drugs, are commonly used in the treatment of osteoporosis and cancer that has spread to the bone. Doctors prescribe intravenous bisphosphonate therapy, which was the subject of the precautions, for patients with cancer that has spread to the bone to help decrease associated pain and fractures. In addition, emerging research is exploring the ability of intravenous bisphosphonate therapy to inhibit the spread of some cancers to the bone. Osteonecrosis literally means death or “necrosis” of bone. According to the National Osteonecrosis Foundation, the many risk factors for osteonecrosis can be divided into two categories: definite and probable. Definite risk factors include major trauma, fractures, dislocations, Caisson Disease, Sickle Cell Disease, post- irradiation, chemotherapy, Arterial Disease, and Gaucher’s Disease. Probable risk factors include corticosteroids, blood clotting, alcohol, lipid disturbances, connective tissue disease, pancreatitis, kidney disease, liver disease, lupus, and smoking. Osteoporosis Doctors also prescribe an oral dose of bisphosphonates for patients at risk for osteoporosis to help delay the onset of disease by slowing the natural progression of bone tissue destruction, or to reduce its complications, Orally administered bisphosphonates were not the subject of the drug precautions. The most common brand name is Fosamax. The FDA noted that there have been anecdotal reports of ONJ in associations with oral bisphosphonates administered for osteoporosis. Reports seem to be increasing implicating the taking of Fosamax and Osteonecrosis of the Jaw (ONJ). The FDA recognizes additional risk factors associated with the development of osteonecrosis (not limited to the jaw) in cancer patients, such as female sex, advanced age, edentulous regions, combination cancer therapy, blood dyscrasias/metastatic disease, anemia coagulopathy, surgical dental procedures, and prior infection. Are you currently using any of the following? Or have you ever used previously? Have you used any other drug prescribed to decrease the resorption of osteoporosis? _____________________________ If yes, when and how long?_______________________________________________________________________________ I have been made aware of the current information regarding my medication and its potential risks and side effects. PATIENT OR GUARDIAN SIGNATURE ________________________________________________ Date______________

Source: http://toothhut.com/forms/fosamax.pdf