Fosamax

Fosamax, also known by the generic name alendronate, is typically prescribed to post menopausal women to treat or prevent osteoporosis. The drug, manufactured by Merck & Co., is also frequently used in the management of advanced cancer. However, Fosamax recently has been linked to osteonecrosis of the jaw (ONJ), a rare and serious condition that causes the jaw bone to partially crumble and die. ONJ is also known as “bone death of the jaw.” The majority of the reported cases are in cancer patients who are having, or have had, a dental procedure.

Fosamax is Merck & Co.’s second-biggest selling drug, with more than 22 million prescriptions in 2005 alone. The first is its defective prescription medication Vioxx, which is facing a deluge of litigation. Reports in the last few years have linked Fosamax and similar drugs, known as bisphosphonates, to ONJ. Bisphosphonates are not metabolized by the body, causing the drug to persist in bone in high concentrations for months and sometimes years after a patient stops using the drug.  Fosamax is the only bisphosphonate taken orally.

Fosamax is probably the best-known brand-name drug for preventing hip fractures and deteriorating bones that often destroy the quality of life for older women. Millions of women have taken the drug since it was first marketed in 1995. In 2005, Fosamax generated $3.2 billion in sales, outselling all other major oral osteoporosis remedies.

In July 2005, Merck added language about ONJ to Fosamax's label more than a year after a 2004 request from the Food and Drug Administration, which had reviewed reports of osteonecrosis. It is not a warning, and many doctors and lawyers have found the wording to be inadequate.

Bisphosphonates remain in bone indefinitely. Symptoms of bone death in the jaw include:

1. Facial pain
2. Gum swelling
3. Infection of the gums
4. Loosening of the teeth, or tooth loss
5. Poor healing of the gums
6. Numbness, or a feeling of heaviness in the jaw
7. Exposed bone

Fosamax can also irritate the esophagus, and care must be taken in order to avoid such irritation. Recently, researchers discovered that taking Fosamax in combination with the popular arthritis drug Naproxin may increase the risk of developing stomach ulcers.

To diagnose osteonecrosis of the jaw, doctors may use X-rays or tests for infection. Treatments for osteonecrosis of the jaw may include long-term antibiotic use, oral rinses, and removable mouth appliances. Minor dental work may be necessary to remove injured tissue and reduce sharp edges of the bone, but more invasive surgery is typically avoided because it may make the condition worse. Unfortunately for Fosamax injury victims, ONJ is extremely resistant to even the most aggressive treatments.

If you or a loved one has used Fosamax and suffered side effects, please call Keel O'Malley, L.L.P. at (252) 823-2266 or toll free (800) 755-1987 or submit our online questionnaire. The initial consultation is free of charge, and if we agree to handle your case, we will work on a contingency fee basis, which means we get paid for our services only if there is a monetary recovery of funds. In many cases, a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. Please call right away to ensure that you do not waive your right to possible compensation.

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