Fosamax (alendronate sodium) is drug prescribed for the treatment or prevention of osteoporosis, or bone los, in post menopausal women; to increase bone mass in men with osteoporosis; and to treat Paget’s disease. Fosamax is a member of the class of drugs known as biphosphonates. By 2004 Fosomax was the most commonly dispensed bisphosphonate in the United States and accounted for 22 million prescriptions. Recently a connection between the entire class of biphosphonates and Osteonecrosis of the Jaw, or Dead Jaw, has been identified.

Osteonecrosis of the Jaw is a serious and destructive process involving bone tissue and requires aggressive surgery to remove the affected necrotic, or deceased, bone, as well as long- term antibiotic therapy. It can occur following minor trauma from tooth extraction or dental surgery, and oftentimes may occur even in the absence of these procedures.

Fosamax, a drug prescribed to treat osteoporosis, may cause a condition called osteonecrosis of the jawbone. In the May 2004 issue of the Journal of Oral and Maxillofacial Surgeons , a direct relationship was identified between Fosomax use and osteonecrosis of the jaw, prompting both the US, Food and Drug Administration and Novartis,( the manufacturer of bisphosphonates used in cancer chemotherapy) , to re evaluate the safety of biphosphonates. In January 2005 FDA advised Merck, the manufacturer of Fosomax to revise its labeling, and in July 2005, Footman labeling was revised to alert the public to this cancerous risk.

Biphosphonates such as Fosamax (Alendronate Sodium), Zometa (Zoledronate), Didronel (Etidronate), Aredia (Pamidronate), Actonel (Risedronate), and Boniva (Ibandronate) are commonly used to treat, prevent, and even reverse bone loss associated with osteoporosis, chemotherapy, and other bone loss disorders. The Strongest forms of bisphosphonates are commonly used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously and usually for longer periods of time.

Fosamax (alendronate), a drug that has been on the market for almost 10 years, has been linked to osteonecrosis of the jaw (ONJ). Otherwise known as "dead jaw", osteonecrosis is a severe condition in which the jaw dies and is unable to regenerate, eventually leading to extreme pain and exposed bone in the mouth. Fosamax is part of a class of drugs known as bisphosphonates, which are used to treat osteoporosis and bone pain caused by some types of cancer. Bisphosphonates are often used in the management of certain cancers—such as lung, breast, prostate, and multiple myeloma—where cancer has metastasized (spread) to the bone. Bisphosphonates are absorbed into the bone tissue where the drug may remain for some period of time. It is believed that the drugs interfere with the deposition and absorption of calcium in the bone possibility leading to the degeneration of the bone tissue, and may apply to both oral and intravenous administration of the drug.

What is Osteonecrosis of the Jaw (ONJ)?

Also known as "dead jaw", osteonecrosis is the destruction of bone tissue. Osteonecrosis of the jaw is a painful, deteriorative condition that involves soft-tissue swelling in the mouth, infection, loosening of the teeth, drainage, and exposed bone. It is often the result of blood not properly reaching the bone.

There are several other bisphosphonate drugs on the market, all of which have been linked to ONJ. Actonel® is an oral bisphoshonate drug similar to Fosamax and is manufactured by Procter & Gamble Pharmaceuticals. Aredia® (pamidronate disodium) and Zometa® (zoledronic acid), both manufactured by Novartis, now include labeling on the drugs to include reports of osteonecrosis of the jaw in people who have taken bisphosphonates.



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