Fosamax Jaw Necrosis Risk Identified in New Study

According to new research from the University of Southern California, School of Dentistry, Fosamax side effects have been linked with the development of osteonecrosis of the jaw (ONJ), a debilitating condition where the jaw bone deteriorates and decays.

Fosamax (alendronate sodium) is an oral bisphosphonate medication which is prescribed to treat osteoporosis by increasing bone density and reducing the risk of fractures. It is a widely prescribed medication, generating annual sales of over $3 billion.

Osteonecrosis of the jaw, also known as ONJ or jaw necrosis, is caused by insufficient blood flow to the jaw which causes the bone to decay and die. The Jaw damage is irreversible and often results in exposed areas of bone inside the mouth. In many cases, infected portions of the jaw are ultimately surgically removed.

Although Merck & Co., which manufactures Fosamax, has previously denied that there is a direct connection between oral drugs like Fosamax and ONJ, a number of users have reported developing the disabling jaw condition and the first known Fosamax ONJ lawsuit was filed against Merck in 2006.

The new study, which is published in the current issue of the Journal of the American Dental Association, is the first to investigate whether there is a direct link between oral osteoporosis drugs like Fosamax and jaw necrosis.

Researchers found that even short-term use of Fosamax increased the risk of jaw damage, with 9 out of 208 patients taking the oral bisphosphonate for any length of time developing ONJ. With a prevalence rate of about 4%, or one in 25 patients, this is much more frequent than had been previously suspected.

There are currently over 600 Fosamax lawsuits pending against Merck which have been filed by users who have developed jaw necrosis after taking the drug. All federal cases have been consolidated for pretrial litigation as part of an MDL, or multidistrict litigation in the U.S. District Court for the Southern District of New York.

The first Fosamax jaw necrosis lawsuit is scheduled for trial to begin on August 11, 2009, with the second trial on October 27, 2009 and the third on January 11, 2010.