June 1, 2012 — A new study suggests that the risk of esophageal cancer associated with Fosamax (alendronate) may be higher than expected. The study analyzed adverse events reported to the U.S. Food and Drug Administration (FDA) from 1995 through 2010, and found that 128 cases of esophageal cancer were associated with bisphosphonates, a class of drugs that includes Fosamax. In fact, Fosamax was associated with 75% of the cases of esophageal cancer.
The new study has found a higher number of Fosamax esophageal cancer cases than expected. In 2009, an FDA analysis of adverse events found just 23 cases of esophageal cancer linked to Fosamax. In total, the recent analysis found 96 cases of esophageal cancer linked to Fosamax.
The FDA issued a public safety warning in July 2011 regarding the risk of esophageal cancer, but concluded that the evidence was “conflicting” and the benefits of the drug outweighed these risks.
This most recent study has found that Fosamax is associated with 6.4-times more cases of esophageal cancer than any other drug in the bisphosphonate class. It is possible that there are other drugs in this class that have a lower risk of side effects and are equally effective.
In conclusion, the researchers recommended that people who are at risk of esophageal cancer and also for people with mucosal abnormalities.
The bisphosphonate class of drugs, including Fosamax, have also been associated with an increased risk of esophagitis (inflammation and swelling of the esophagus). Over time, the use of these drugs increases the risk of erosive esophagitis and persistent mucosal abnormalities. This may help explain the increased risk of esophageal cancer observed in the study.
The results of the study were published as an abstract and presented at a medical research conference. They have not been peer-reviewed and should be considered preliminary.