With hundreds of Fosamax lawsuits making their way through U.S. courts, a new study has found yet more evidence that Fosamax and similar drugs known as bisphosphonates can cause the bone-decaying disease, Osteonecrosis of the Jaw (ONJ). According to the study, which was published in the International Journal of Oral and Maxillofacial Surgery, patients being treated with bisphosphonates, the drug class that includes Fosamax, are more likely to develop ONJ following tooth extractions.

ONJ, also known as Dead Jaw Syndrome, occurs when the jaw bone is exposed and begins to starve from a lack of blood. This ultimately leads to bone weakness and bone death. Known risk factors for ONJ include cancer treatments (including radiation and bisphosphonate treatment), infection, and steroid use. Fosamax’s link to Dead Jaw Syndrome has been known for quite some time. In 2005, the U.S. Food & Drug Administration (FDA) ordered Merck & Co., the maker of Fosamax, to add warnings about the jaw disorder to its label.

This new study analyzed data from 3, 216 patients who underwent tooth extraction between April 2006 and June 2009, of whom 126 received bisphosphonates. A total of five patients who received bisphosphonates developed ONJ compared with one patient who did not. Intravenous bisphosphonate use resulted in a significantly higher incidence of ONJ than oral drugs likes Fosamax. The study also found that bisphosphonate-induced ONJ was significantly associated with alveolar bone loss among patients who received bisphosphonates after extraction, suggesting that severe periodontitis may be a risk factor for the condition.

“Preventive and therapeutic treatment of oral bacterial infection before extraction might be important in preventing BIONJ in patients with BP administration,” the study authors suggested.

Dead Jaw Syndrome is far from the only side effect Fosamax users need to worry about. In October 2010, the FDA warned that people taking Fosamax and other bisphosphonates for osteoporosis are at risk of suffering atypical femur fractures. Just this past May, an analysis commissioned by the agency and published in the New England Journal of Medicine found that there was little benefit in taking Fosamax and similar drugs for longer than five years. The report cited serious Fosamax side effects, including ONJ, femur fractures and esophageal cancer.

A number of Fosamax lawsuits are currently pending in a Mass Tort proceeding in In re: Fosamax Litigation (No. 282 N.J. Super. Ct.), in Superior Court of New Jersey, Atlantic County. The Fosamax lawsuits allege Merck concealed the serious risks associated with the drugs, and failed to adequately warn the public about those risks.

Published October 24, 2012 by