Actonel and Osteonecrosis of the Jaw or Dead Jaw

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Actonel (known generically as risedronate sodium) is a commonly prescribed drug belonging to the class of drugs known as bisphosphonates. Bisphosphonates have been found to slow the rate of bone loss and are used in the treatment and prevention of osteoporosis in post-menopausal women. Around 36 million women use medications such as Actonel to reduce the chance of developing osteoporosis or improve bone density if they have already contracted the illness. Approved for human consumption in 1998, Actonel is produced by Proctor & Gamble and marketed by it marketing partner Sanofi-Aventis.

In the body, bone is contantly forming and dissolving. In osteoporosis, bone dissolves faster than it is formed, causing the bone to lose density. Actonel works by blocking the cells that cause bone dissolution. By blocking these cells, Actonel allows the bone to gain density by forming faster than it dissolves. This makes the bones stronger, effectivly reducing the risk of stress fractures, which are painful and in many cases can be life threatening.

Medical professionals recommend that individuals taking Actonel avoid tooth extractions and other major dental procedures while on the drug, due to a link found between Actonel usage and a bone disease called Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw. The link between Actonel and ONJ was discovered in 2004, six years after Actonel was released to the public.

Osteonecrosis of the Jaw is a condition in which the jaw suffers literal bone death. While investigating the causes of ONJ, researchers have suggested that bisphosphonate medications can prevent the creation of blood vessels in the jawbone. The inability to produce new blood vessels in the jawbone compromises the natural healing process and bone tissue in the jaw fails to heal after minor trauma, such as a tooth extraction. This in turn causes the bone to remain exposed. The exposure of areas of the jawbone can ultimately lead to infection, rotting, and bone death.

The prevention and early treatment of patients is extremely important in saving the bones of the jaw. The condition can be asymptomatic for months and many symptoms will only develop after trauma to the mouth. The most common signs and symptoms of ONJ 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 the disease is irreparable.

When 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 decided to issue a warning to healthcare professionals detailing the increased risk of ONJ while on medications such as Actonel. While the warning indicated that clinical trials conducted before the approval of the drug did not demonstrate an increased risk of ONJ, the FDA admitted that sometimes the long-term effects of a drug are not revealed until after the drug has been released. It is estimated that dozens of cases of osteonecrosis of the jaw will occur annually 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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