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Osteonecrosis of the Jaw (ONJ)
Osteonecrosis of the Jaw or Dead Jaw
In 2004, a report from the Surgeon General stated that 1 in 2 women over the age of 50 will break a bone in their remaining lifetime due to osteoporosis. Every year, there are more women that suffer an osteoporosis-related fracture than have a stroke, heart attack or are diagnosed with breast cancer combined. Healthcare professionals consider osteoporosis a serious health issue for women.
Osteoporosis is a disease that causes gradual weakening of the bones, often leading to painful, sometimes life-threatening fractures. Because the bone loss is gradual, many people do not realize they have the disease until they suffer a fracture, and even then, testing is needed to determine whether osteoporosis is the cause. Around 10 million people already have the disease, 80% of which are women. Another 18 million have low-bone density. It is estimated that over 36 million women take medications, such as Actonel, to treat, prevent, or slow osteoporosis.
Actonel (known generically as risedronate sodium) is a prescription medication used to prevent and treat osteoporosis in post-menopausal women. It belongs to a class of drugs called bisphosphonates which are used to strengthen bones by improving bone density. Another Actonel drug use is to treat Paget’s disease, a chronic disease that results in enlarged and deformed bones. Actonel is produced and marketed by Proctor & Gamble and Sanofi-Aventis. The drug was granted FDA approval for human consumption in March of 1998.
Actonel works by blocking the cells that cause osteoporosis, which increases bone density. In the human body, bone is continuously formed and dissolved. Osteoporosis occurs when the dissolving rate is faster than the forming rate. Actonel slows down the rate at which bone dissolves, thereby increasing the amount of bone. Actonel is a long-term medication, with many consumers taking it for years or the rest of their life. The common side effects of Actonel include headache, nausea, flu-like symptoms, bone pain, and constipation.
Individuals on Actonel or other bisphosphonates should avoid tooth extractions and other major dental procedures while taking the medication. Actonel, as well as the entire bisphosphonate drug class, has been linked to the side effect Osteonecrosis of the Jaw (ONJ), also called Dead Jaw. ONJ is a serious bone disease in which the jaw bone refuses to heal after minor damage, such as with a tooth extraction, causing infection, rotting, and eventual bone death. In serious cases, the ruined bone must be removed through surgery. Healthcare professionals state that prevention of ONJ and early treatment of those who contract the disease is vital to preserve the jaw bone.
The link between bisphosphonates, such as Actonel, and ONJ was discovered in 2004, six years after Actonel was released to the public. After the findings were published in the Journal of Oral and Maxillofacial Surgeons, the US Food and Drug Administration (FDA) and the drug manufacturer, Proctor & Gamble, issued a warning to healthcare professionals and the general public about the increased risk of ONJ while on medications such as Actonel. Experts estimate that more than 2,400 individuals taking Actonel or other bisphosphonates have suffered jaw bone decay and death due to ONJ since 2001, some suffering from such severe pain and debilitation that they have become bedridden.
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