Fosamax, a drug developed and manufactured by pharmaceutical giant Merck, was approved by the U.S. Food and Drug Administration (FDA) in 1995 for the treatment and prevention of osteoporosis in women. Fosamax was later approved for the treatment of osteoporosis in men and for Paget's disease. Fosamax is now the market leader of drugs prescribed for osteoporosis, with 22.4 million prescriptions written for the medication last year alone.

What is Fosamax?

Also known by the generic name, alendronate sodium, Fosamax belongs to a class of drugs known as nitrogenous bisphosphonates. Along with Fosamax, nitrogenous bisphosphonates include the drugs marketed as Zometa, Actonel, Aredia, and Bondronat. Bisphosphonates were first studied in the 1960's for use in bone disorders because of their ability to hinder the loss of important bone minerals. Prior to the 1990's, non-nitrogenous bisphosphonates, such as Didronel, were prescribed as treatments for Paget's disease and to aid in bone formation following total hip replacement surgery and spinal cord injury. In the early 1990's, the FDA approved intravenous nitrogenous bisphosphonates for the treatment of bone loss in cancer patients. In 1996, Fosamax became the first bisphosphonate drug approved to treat and prevent osteoporosis in postmenopausal women.

Nitrogenous bisphosphonates, such as Fosamax, prevent bone loss differently than non-nitrogenous bisphosphonates. Nitrogenous bisphosphonates are not metabolized by the body, and therefore may remain in the body for years before they break down. They bind to an enzyme called FPPS (farnesyl diphosphate synthase), preventing the formation of certain essential metabolites that ordinarily connect small proteins to the cell membrane of osteoclasts. Osteoclasts are cells that remove minerals from bones, and the lack of crucial protein connections prevents them from surviving long enough to carry vital minerals away from the bone. This preservation of bone minerals maintains or increases the density of bones.

Fosamax and Osteonecrosis of the Jaw

Since the FDA approved Fosamax, various studies by dentists, endodontists, and maxillofacial surgeons have made note of a possible link between Fosamax and an irreversible and deforming jaw condition known as osteonecrosis of the jaw (ONJ). The studies have added to the growing concerns of orthopedists, who suggest that Merck's intense marketing campaign for Fosamax - which targets women in their 40's and 50's at the onset of menopause - promotes Fosamax prescriptions for women who do not need the drug and are not at risk of developing osteoporosis in the near future.

Fosamax Litigation

This past year, several lawsuits, one involving up to 300 Fosamax patients, were filed against Merck. The lawsuits assert that Merck hid the connection between Fosamax and ONJ and that Merck has still not complied with the FDA's request that the pharaceutical company change Fosamax's label to adequately warn doctors and patients of the risk of developing ONJ.

If you or a family member has used Fosamax and experienced adverse side effects, such as osteonecrosis of the jaw, you should contact a physician immediately. If you would like to discuss your rights regarding your injury, please fill out the short evaluation form below and a member of Seeger Weiss's experienced staff will contact you. Initial attorney consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.