Risk of osteonecrosis of the jaw with Fosamax

By Austin Kirk
Posted July 2, 2007

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A study published last week provides further evidence directly linking bisphosphonates to an increased risk of jaw bone decay, known as osteonecrosis of the jaw.  The study involved intravenous bisphosphonates which are used to treat bone cancer, osteoporosis and other conditions.  Although the study did not address the risks associated with oral bisphosphonates, such as Fosamax, the popular osteoporosis drug has been associated with an increased risk of osteonecrosis of the jaw after long term use.

>>INFORMATION: Fosamax jaw problems

Osteonecrosis of the jaw (also known as jaw death or jaw decay) is a severe form of damage to the jaw bone which is extremely painful and potentially disfiguring.  It is an irreversible condition in which the jaw actually decays and dies.  It is associated with jaw infection and portions of exposed bone inside of the mouth.  In severe cases, surgery is required to remove portions of the jaw bone which have decayed.

The bisphosphonate study was released June 26, 2007 on the website for the Journal of the National Cancer Institute.  Researchers from the University of Texas, Galveston, followed approximately 14,000 patients with cancer-treating bisphophonates over a 6 year period, as well as 28,000 individuals not taking one of the drugs.  The study found that those who received an intravenous bisphosphonate, such as Aredia (pamidronate) or Zometa (zoledronate), underwent facial surgery at a rate 3.2 times that of the control group and faced a risk 11.2 times higher for developing an inflamed jaw bone.

>>INFORMATION: Bisphosphonate side effects

Earlier bisphosphonate research regarding the risk of osteonecrosis of the jaw involved much smaller populations and gave rise to a great deal of speculation.  The authors of this study indicated that these findings definitely draw a link between the drugs and an increased risk of the jaw bone disease .  It also indicates that those who receive higher doses of the bisphosphonate drugs are more likely to experience jaw problems.

FOSAMAX AND OSTEONECROSIS OF THE JAW

Although the study did not specifically follow those who used Fosamax and other oral bisphophonates, the rare jaw condition has been seen in hundreds of individuals who took Fosamax over a long period of time, even if they had no exposure to an intravenous bisphosphonate.

Fosamax was approved in October 1995 by the U.S. Food and Drug Administration, and was the first non-hormonal therapy treatment for postmenopausal osteoporosis in the United States.  Fosamax is currently the most prescribed drug for osteoporosis and in 2003 was the 19th most prescribed drug in the U.S., with approximately 20 million users and average annual sales of about $3 billion dollars.

The half life of Fosamax is very long, with half of the medication remaining in the body even after 10 years.  The manufacturer promotes the drug for long term use, which results in dose accumulation over years of taking the medication.  Many believe that the risks associated with Fosamax after long-term use is equally as likely to lead to osteonecrosis of the jaw as the risk associated with intravenous bisphosphonates. 

In July 2005, following a request by the FDA, the warning label for Fosamax was amended to indicate the risk of osteonecrosis associated with bisphosphonates.  However, the manufacturer, Merck, continues to minimize the risk and has failed to adequately warn users and the medical community.

The Fosamax lawyers at Saiontz & Kirk, P.A. are pursuing osteonecrosis of the jaw lawsuits against the manufacturer of the osteoporosis drug.  If you, a friend or family member have been diagnosed with this permanent and disfiguring jaw decay, request a free consultation.

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