The most recent Fosamax study, presented to the American Society of Clinical Oncology 2012 annual meeting (abstract found online at asco.org), examined the link between the use of bisphosphonates—a class of drug that includes Fosamax—and the development of esophageal cancer. According to the study's authors, led by Beatrice Edwards, in 2009, the US Food and Drug Administration (FDA) reported 23 patients who developed esophageal cancer within two years of starting alendronate (the generic of Fosamax) therapy, while 31 cases were identified in Europe and Japan.
Researchers examined the FDA's Adverse Event Reporting System (AERS) to determine if the use of bisphosphonate medications was linked to an increased risk of esophageal cancer. They found 128 cases of esophageal cancer that were associated with bisphosphonate use, including 96 involving alendronate.
"Our analysis of FDA AERS identifies a larger number of cases of esophageal cancer than previously described, and a significant safety signal with alendronate use," researchers wrote. They recommended that bisphosphonates not be used in patients with Barrett's esophagus or persistent mucosal abnormalities.
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Merck has already faced multiple lawsuits concerning Fosamax, with the drugmaker winning all but one of the bellwether trials.