What is Osteonecrosis of the Jaw?

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In March of 1998, the US Food and Drug Administration approved the use of a new drug called Actonel (known generically as risedronate sodium), a prescription medication used to treat and prevent osteoporosis in post-menopausal women. Actonel belongs to a class of drugs known as bisphosphonates which are used to slow the rate of bone loss in osteoporosis, as well as treat other diseases. Manufactured and marketed by Proctor & Gamble and their partner Sanofi-Aventis, Actonel quickly became one of the leading medications in the country for treating osteoporosis. It is estimated that close to 36 million women use medications such as Actonel to reduce their chances of developing osteoporosis or improve bone density if they have already contracted the illness.

A link between bisphosphonates, such as Actonel, and a debilitating bone disease called Osteonecrosis of the Jaw (ONJ) was found 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 issued a warning to healthcare professionals and the general public about the increased risk of ONJ 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 ONJ, some suffering from such severe pain and debilitation that they have become bedridden.

Osteonecrosis of the Jaw

Osteonecrosis of the Jaw, also known as Dead Jaw, is a disfiguring and disabling condition where the jaw bones suffer literal bone death through infection and rotting. When investigating the causes of ONJ, researchers have suggested that bisphosphonate medications such as Actonel can prevent the creation of new blood vessels in jawbone tissue. Without being able to produce new blood vessels in the jawbone, the natural healing process is compromised. The bone tissue in the jaw fails to heal after minor trauma, such as a tooth extraction, which causes the bone to remain exposed. This 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 jawbone. ONJ can be asymptomatic for many weeks or months and there are a number of ONJ symptoms which only develop after trauma to the mouth. The most common signs and symptoms of osteonecrosis of the jaw include pain, poor healing of the gums, swelling or infection of the gums, numbness or a feeling of heaviness in the jaw, loosening of the teeth, drainage, and exposed bone.
Patients with a mild form of ONJ may not show any symptoms at all. 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 is a very serious procedure which can result in the patient being unable to chew solid food. Antibiotics must be taking during and after dental surgery and may be required for an extended length of time. Close monitoring must follow the surgical procedure as improper treatment can result in septicemia and death.

Cases that go undiagnosed and untreated can result in bone collapse leaving the sufferer disfigured. Bone death is irreversible and the damage done by ONJ is irreparable. An inability to work, tend to business affairs, embarrassment, and an inability to interact with family and friends in the usual manner all contribute to emotional distress in patients suffering from ONJ. It is estimated that dozens of cases of osteonecrosis of the jaw will occur each year in patients taking Actonel and other bisphosphonates.

Do I have an Actonel Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Actonel lawsuits. We are handling individual litigation nationwide and currently accepting new Actonel cases in all 50 states.

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