Fosamax and ONJ
A New study says taking Fosamax might be at risk for developing major problems with their jaws than
scientists believed before, according to the Journal of the American Dental Association.
(Jan 10, 2012 -- One of the major problems concerned in this study is osteonecrosis of the jaw
(ONJ), which is as jawbone death, and there have also been earlier studies which had established
a risk in individuals on the intravenous form of Fosamax, when people receive a higher dose of
the medication than most people do when taking it in pill form. The users of Fosamax who have
been taking the drug in pill form, the previous research done on this particular form has shown
that the risk of ONJ is negligible.
A report issued by the United States Food and Drug Administration (FDA) in 2004 on Fosamax
and its generic versions (zometa, aredia, actonel), stated that the package labeling on Fosamax
should be revised to warn doctors and patients about the potential Fosamax jaw problem.
Unfortunately, Merck didn’t revise the Fosamax label until almost a year later in 2005.
The following are known symptoms of ONJ: an irregular sore with exposed bone in either the
upper or the lower jaw, pain in the infected jaw, inflammation and swelling in the infected jaw,
loosening of teeth, evidence of infection, including fever and possible pus discharge, numbness,
tingling, or other sensation changes.
With regards to ONJ Merck posted this on its website: In controlled clinical trials involving more
than 28,000 patients (over 17,000 of whom were treated with Fosamax), contributing as much as
10 years' data with alendronate, there have been no reports of ONJ. This includes 3000
osteoporosis patients taking alendronate for 3-5 years and 800 patients taking alendronate for 8-
10 years. In worldwide post-marketing experience with Fosamax/Fosamax Plus D, rare reports
consistent with osteonecrosis of the jaw have been received. Many of these reports lack
sufficient clinical details to make definitive assessments and/or are confounded, particularly
since a generally accepted definition of ONJ in the general population is unknown.“
While there are still several Fosamax complaints waiting for the courts to decide on, one thing is
for certain, ONJ is a serious illness and one of the Fosamax side effects all women should be
wary of. If you believe that you are currently experiencing ONJ due to your Fosamax use,
consult with your doctor as soon as possible.
###