Drug Injury

Fosamax® and Osteonecrosis of the Jaw

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Fosamax® Use Leading to Osteonecrosis of the Jaw

Fosamax® (alendronate), a drug that has been on the market for almost 10 years, has been linked to osteonecrosis of the jaw (ONJ) (1). 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 an oral drug used in the treatment of osteoporosis (bone loss) in post-menopausal women; to increase bone mass in men with osteoporosis; and to treat Paget’s disease (a life-long chronic condition that results in abnormal bone growth) (2).

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. Fosamax is the most commonly dispensed bisphosphonate in the United States and accounted for 22 million prescriptions by 2004 (2). 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, once taken, remain in the bones indefinitely (1). The coauthor of a report on osteonecrosis of the jaw resulting from bisphosphonate use, published in the Journal of Oral and Maxillofacial Surgery, says that drugs such as Fosamax could upset the delicate balance between the cells that put calcium in bone and the cells that take calcium away (1). His report prompted the Food and Drug Administration (FDA) to post a review saying that osteonecrosis of the jaw is a risk for all bisphosphonates, which includes both oral and intravenous doses.

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 (1). 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.

Free Consultation

Osteonecrosis of the jaw is a painful condition that can result in serious health complications. Contact a Fosamax lawyer at our firm if you have taken any bisphosphonate drugs and later suffered osteonecrosis of the jaw. We will put our considerable resources behind all cases in which dangerous drugs have harmed innocent victims. Call us immediately for a free consultation and speak with a Fosamax lawyer today. We want to help.

Sources:

• Drug Link to Death of Jawbone, by Rita Rubin, USA Today. Accessed on 04/14/06 from www.USAToday.com.
• IMS Health, National Prescription AuditPlus, On-Line, May 2001 - April 2004, Data Extracted May 2004. Appears in FDA’s One Year Post Exclusivity Adverse Event Review: Alendronate accessed on 04/14/06.

This law firm is not associated with, sponsored by, or affiliated with the Journal of Oral and Maxillofacial Surgery, the Food and Drug Administration, Merck & Co., Inc., Procter & Gamble Pharmaceuticals, Novartis Pharmaceuticals, USA Today, or IMS Health.

Fosamax® is a registered trademark of Merck & Co., Inc. and is used here only to identify the product in question.

Actonel® is a registered trademark of Procter & Gamble Pharmaceuticals and is used here only to identify the product in question.

Aredia® and Zometa® are registered trademarks of Novartis Pharmaceuticals, Inc. and are used here only to identify the products in question.

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