About Fosamax

Fosamax (alendronate) is a drug compound that alters the cycle of bone formation and breakdown in the body. It is prescribed to prevent osteoporosis and to treat Paget's disease. Osteoporosis is a bone disease which affects many post-menopausal women. Reduction in the density of bone mineral and changes in the variety of protein material in the bones make the bones frailer, putting patients at risk of fracture.

Paget's disease, named after the British surgeon who first described it, Sir James Paget, is a chronic disorder that results in over-large and deformed bones due to excessive formation and breakdown of bone tissue. Patients suffering from Paget's disease have weak bones and suffer frequent fractures and painful arthritis. Fosamax aids patients with osteoporosis and Paget's disease by inhibiting bone material resorption. Fosamax adheres to osteoclasts, cellular material that affects the natural turnover of bone tissue. Osteoclasts then remain in the body, strengthening the stability of the bone.

FOSAMAX HAS NOT YET BEEN RECALLED BY ITS MANUFACTURER

Fosamax is manufactured and marketed by Merck and Co., makers of the controversial arthritis drug Vioxx. Merck has been found negligent in some lawsuits by personal injury victims who took Vioxx and suffered heart attacks, strokes and cardiac death as a result. Juries found that Merck withheld data from the public that proved Vioxx was not a safe drug. Could the same be true of Fosamax? Personal injury lawyers are presently investigating that possiblity.

Osteonecrosis of the Jaw (ONJ)

Osteonecrosis of the Jaw, or ONJ, is a rare but recognized side effect of bisphosphonate drugs. Bisphosphonate drugs include Fosamax and the lesser-known cancer drugs Aredia and Zometa which are administered intravenously. ONJ is sometimes known as jawbone necrosis or "dead jaw."

ONJ is a painful and debilitating condition that involves tissue death and loss of bone in the jaw. It resembles a condition that was known as "phossy jaw" in the 19th and early 20th century that was suffered by industrial workers in match plants who worked with white phosphorus. Chronic exposure to white phosphorus vapor, which was the active ingredient of most matches manufactured between the 1840s through the 1910s, caused a deposition of phosphorus in the jawbone of plant workers. Injured workers would begin suffering painful toothaches and swelling of the gums, but over time, the jaw bone would begin to abscess, causing painful disfiguration of the face. The jawbone would gradually rot away, and drainage from the dying jawbone tissue was exceedingly foul-smelling. Workers would have to have their jawbones surgically removed or else they would die.

ONJ and Bisphosphonate Drugs

Fosamax, Aredia and Zometa

The Medical Journal of Australia reported in March 2005 that the Adverse Drug Reactions Advisory Committee (ADRAC) of Australia had received 13 reports of osteonecrosis of the jaw associated with bisphosphonate use. In May of 2005, the U.S. FDA required Novartis to update the warning labels for Aredia and Zometa to include a precaution that patients on bisphosphonates who also had dental procedures were at high risk for developing osteonecrosis of the jaw (ONJ).

The "Dear Doctor" letter issued by Novartis Pharmaceuticals Corporation advises physicians that patients who develop ONJ may exacerbate their conditions while on bisphosphonate therapy if they have additional dental surgery. According to the American Dental Association, Dr. Robert Marx, a maxillofacial surgeon, first reported a high incidence of patients with ONJ in a letter to the editor of the Journal of Oral Maxillofacial Surgery in 2003. His patients had been taking Aredia or Zometa. Dr. Marx observed that very few of his patients were recovering well from what was minor dental surgery. Instead, their surgery led to infection and then a cascade of other problems that ultimately became ONJ. His fundamental finding was osteonecrosis of the jaw.

Sources: American Dental Association Website Resources: Osteonecrosis;Patrick M Purcell and Ian W Boyd, "Bisphosphonates and osteonecrosis of the jaw," Medical Journal of Australia 2005; 182 (8): 417-418.

Warning Signs of “Dead Jaw” or ONJ

• Pain, swelling, or infection of the gums
• Loosening of teeth
• Poor healing of the gums
• Numbness or the feeling of heaviness in the jaw

Some possible factors that may increase the risk of osteonecrosis include:

• Radiation therapy to the head or neck
• Chemotherapy
• Steroid therapy (for example, cortisone)
• Underlying cancer
• Anemia (low blood count) and other blood related disorders
• Infection
• A history of poor dental health
• Gum disease or dental surgery (such as pulled teeth)
• Alcohol abuse or cigarette smoking
• Poor nutrition
• Poor blood circulation or clotting problems

Drugs that may be linked to ONJ:

• Fosamax
• Aredia
• Zometa

Source: American Dental Association Website Resources: Osteonecrosis.

Why You Should Talk to a Personal Injury Attorney about Fosamax

Osteonecrosis of the jaw, or ONJ, sometimes known as dead jaw or phossy jaw, is a debilitating, and disfiguring condition. If you are suffering from dental pain and have been taking Fosamax for any length of time, you could be at risk, not just right now, but years after you stop taking Fosamax. Evidence suggests that the active ingredient in Fosamax which adheres to bone tissue remains in the tissue for up to ten years, preventing the natural and healthy turnover of bone tissue that would enable your jawbone to recover from infection or necessary dental surgery. You may require medical monitoring and special medical care to insure that you do not suffer the disfigurement and pain that can result from ONJ.

We may be able to help you. Contact us today for a free conversation about your situation. There is never any obligation to hire our firm. Our drug injury team will contact you within one business day to get more information from you and explain the legal implications of your case. We've helped many people get help to deal with their injuries. Contact us today.