Actonel Resources
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Osteonecrosis of the Jaw (ONJ)
Osteonecrosis of the Jaw or Dead Jaw
Dead Jaw, known in the medical community as osteonecrosis of the jaw, is a condition where the bones in the jaw suffer literal death through infection and rotting. In more serious cases, patients may require the removal of large sections of the jaw by a maxilla facial surgeon, dentist or appropriate doctor. This procedure can result in the patient being unable to chew solid food.
When investigating the causes of Dead Jaw, researchers have suggested that bisphosphonate medications such as Actonel prevent the creation of new blood vessels in the jawbone. Without being able to produce new blood vessels, the natural healing process of the jaw is compromised, resulting in wounds from minor trauma remaining open. When the bone tissue fails to heal, the exposure ultimately leads to infection, rotting, and eventual bone death.
The prevention and early treatment of patients using bisphosphonates such as Actonel is extremely important in saving the bones of the jaw. Dead Jaw can be asymptomatic for weeks or months and a number of symptoms only develop after trauma to the mouth. The most common signs and symptoms of Dead Jaw include pain, swelling or infection of the gums, numbness or a feeling of heaviness in the jaw, poor healing of the gums, loosening of the teeth, drainage, and exposed bone.
Cases that go undiagnosed and untreated can result in bone collapse leaving the sufferer disfigured. Bone death is irreversible and the damage done by Dead Jaw is irreparable. An inability to work, tend to business affairs, or interact with family and friends in the usual manner all contribute to emotional distress in patients suffering from Dead Jaw. It is estimated that dozens of cases of Dead Jaw will occur each year in patients taking Actonel and other bisphosphonates.
The link between bisphosphonates, such as Actonel, and Dead Jaw was discovered in 2004 by researchers studying clinical trials. 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 Dead Jaw while on medications such as Actonel. Experts have estimated that more than 2,400 individuals taking bisphosphonates such as Actonel have suffered jaw bone decay and death due associated with Dead Jaw, some suffering from such severe pain and debilitation that they have become bedridden.
While the warning indicated that clinical trials conducted before the approval of Actonel and related medications did not demonstrate an increased risk of Dead Jaw, the FDA admitted that sometimes the long-term effects of a drug do not manifest themselves until after the drug has been released to the general public. Although it was determined that a warning to the healthcare community and general public was warranted, the risk was not determined to be severe enough to require a recall of the medications. It is estimated that dozens of cases of Dead Jaw will occur annually in patients taking Actonel and other bisphosphonates.
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