and Osteonecrosis of the Jaw

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Fosamax (alendronate), a drug that has been on the market for almost 10 years, has been linked to femur fractures and osteonecrosis of the jaw (ONJ). Femur fractures and ONJ (otherwise known as “dead jaw”) are extremely painful conditions.

What Is Fosamax?

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 lifelong 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 reached 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, writes that drugs such as Fosamax could upset the delicate balance between the cells that put calcium in bones 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.

Fosamax Femur Fractures

While Fosamax is supposed to help make bones stronger, there is mounting evidence that Fosamax may be responsible for spontaneous femur fractures in longtime users. The femur is the longest and thickest bone in the human body and extends from the pelvis to the knee.These fractures appear to have occurred with no apparent trauma, and have occurred after tripping (but not falling) over a rug, or from simply walking down the stairs. Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center, said Fosamax bone fracture patients had X-rays that looked like those of car accident victims.

Fosamax Femur Fracture Update:

The FDA officially warned patients and healthcare providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates such as Fosamax. It will undergo a labeling change and include an updated Medication Guide to reflect the risk.The FDA stated, “Atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.”

Fosamax Linked to Osteonecrosis of the Jaw

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.

Legal Update: A woman in Florida was awarded $8 million by a jury after Fosamax destroyed her jaw and caused significant pain. The jury concluded that Fosamax was “unreasonably dangerous due to defective design, and that its defective design was a legal cause of Mrs. Boles’ injury.”

The woman had been taking Fosamax for 10 years. The manufacturer faces about 1,400 lawsuits alleging Fosamax harmed patients.


  1. Drug Link to Death of Jawbone, by Rita Rubin, USA Today. Accessed on 04/14/06 from
  2. 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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