Merck Addresses Cases Of Fosamax-induced Osteonecrosis Of The Jaw, And Three Reports Of ONJ Are Subject Of A Medical Journal Article

(Posted by Tom Lamb at DrugInjuryWatch.com)

This article is a review of recent reports about the safety of bisphosphonates, with an emphasis on Merck’s Fosamax and its association with osteonecrosis of the jaw (ONJ).

We start however with the emerging issue of a possible link between bisphosphonates and the heart condition atrial fibrillation.

In October 2007 the FDA issued an Early Communication of an Ongoing Safety Review entitled "Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)" which is largely based on the following:

An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine describe increased rates of serious atrial fibrillation (defined by the authors as life-threatening or resulting in hospitalization or disability) in two different studies of older women with osteoporosis treated with the bisphosphonates, Reclast and Fosamax.  In both studies, more women who received one of the bisphosphonates (Reclast-1.3% or Fosamax-1.5%) reportedly developed serious atrial fibrillation as compared to women who received placebo (Reclast study-0.5%, Fosamax study-1.0%).  In both studies, the rates of all atrial fibrillation (serious plus nonserious) were not significantly different between groups treated with bisphosphonate versus placebo.

This October 2007 FDA item states that the agency has requested additional information, presumably from the drug companies, in order to evaluate the extent of any association between these bisphosphonates and atrial fibrillation, which is a heart rhythm disorder.  Further, the FDA said this bisphosphonate safety evaluation would take up to twelve months for the agency to complete. 

In September 2007 Merck released its latest proclamation about the safety of Fosamax entitled "Fosamax: Statement by Merck & Co., Inc. Regarding FOSAMAX® (alendronate sodium) and Rare Cases of Osteonecrosis of the Jaw".  The online version of this document (accessed 9/18/07) included the following:

Addendum:  Several independent organizations have published statements related to osteonecrosis of the jaw (ONJ).  Merck & Co, Inc., does not necessarily endorse the perspectives or opinions expressed within these statements.  Also, the prescribing information of currently available intravenous and oral bisphosphonates may provide information about ONJ. To help healthcare professionals in their efforts to understand ONJ, a non-exhaustive list of online addresses associated with independent organizations and available intravenous and oral bisphosphonates is provided as follows.

Information from the National Institutes of Health
http://www.niams.nih.gov/bone/hi/oralhealth_bone.htm

Background from the American Dental Association
http://www.ada.org/prof/resources/topics/osteonecrosis.asp

Statement from the National Osteoporosis Foundation
http://www.nof.org/news/pressreleases/osteonecrosis.htm

Statement from the American Association of Oral and Maxillofacial Surgeons
http://www.aaoms.org/docs/position_papers/osteonecrosis.pdf

Statement from the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis
http://www.ecceo8.org/images/mail/osteonecrosis_jaw.pdf

Statement from the American Society for Bone and Mineral Research
http://www.jbmronline.org/doi/pdf/10.1359/jbmr.0707ONJ

Lastly, in July 2007 there was a new medical journal article about bisphosphonate associated osteonecrosis of the jaw (BONJ), "Oral bisphosphonate associated osteonecrosis of the jaws: three case reports", which appeared in the British Dental Journal.

Be assured that we will continue to follow and report developments concerning the safety of Fosamax and the other bisphosphonate drugs going forward.