Fosamax, also known as alendronate, is a medication used for bone loss, but has been implicated in the serious necrosis of the jaw and other bones, a condition known as "osteonecrosis" (ONJ) – also called "bone death."
Recent studies, however, suggest a link between the use of bisphosphonates, such as Fosamax, and osteonecrosis. This condition is associated with the interference of the blood supply to the bone and the consequential damage that occurs. The majority of the reported cases are in cancer patients who are having, or have had, a dental procedure.
Fosamax is a bisphosphonate manufactured by Merck and used to treat osteoporosis and decreased bone density in postmenopausal women. The drug has been shown to cause osteonecrosis (ONJ) of the jaw, or “dead jaw.” Osteonecrosis is a slow death of bone tissue that occurs because of poor blood supply to the bone. The deterioration is painful and often characterized by mouth swelling, loosening of teeth and exposed bone. Patients who have undergone chemotherapy, taken Fosamax intravenously, have a history of cancer, Paget’s disease or osteoporosis, use steroids while on Fosamax or have a history of major dental work are at an increased risk for ONJ. Other side effects include a risk of severe stomach ulcers when used in conjunction with Naproxin.
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.
The U.S. Food and Drug Administration asked Merck to add a warning to Fosamax's label in August of 2004 and it has yet to comply with that request. In a statement, Merck said that in all of its clinical trials of Fosamax, which have included more than 17,000 patients, it has not had any reports of osteonecrosis of the jaw. Merck said that there have been reports of patients taking Fosamax developing the condition but that doesn't necessarily mean the drug caused it.
Fosamax is taken by nearly 10 million men and women. Fosamax is Merck's second best-selling drug with last year's revenue at $3.2 billion.
