June 1, 2012 — A new study has found higher than expected rates of esophageal cancer associated with Fosamax (alendronate), a popular osteoporosis-prevention drug.

A team of researchers analyzed adverse event reports submitted to the U.S. Food and Drug Administration (FDA) between 1995 and 2010. They found that the entire bisphosphonate class of osteoporosis drugs, including Fosamax, were associated with 128 cases of esophageal cancer. Fosamax was linked to 75% of the cases.

The rate of esophageal cancer is higher than expected. An FDA analysis from 2009 found that Fosamax was associated with just 29 cases of esophageal cancer. This most recent study links Fosamax to 96 cases of esophageal cancer.

On July 21, 2011, the FDA issued a public safety announcement to warn people about the risk of esophageal cancer. The report still determined that the benefits of Fosamax outweighed the risk. However, they found that the evidence was “conflicting” and their review was ongoing.

This most recent study adds further evidence that Fosamax increases the risk of esophageal cancer. In fact, people who were taking Fosamax were 6.4-times more likely to develop esophageal cancer than people taking other bisphosphonate drugs.

The link between the bisphosphonates and esophageal cancer likely has something to do with the risk of esophagitis, in which the esophagus becomes severely inflamed and swollen. Fosamax and the bisphosphonates are also known to affect the mucosal lining of the esophagus, which can cause erosive esophagitis and persistent abnormalities of the esophageal mucous.

The researchers concluded their study by recommending that people who have a history of esophageal cancer, mucosal abnormalities, or other risk factors for this disease should not take Fosamax or other bisphosphonate osteoporosis drugs.

The research was presented at a conference and published as an abstract. Because the study has not been peer-reviewed in a journal, the results should be considered preliminary.


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