FDA: Data Inconclusive on Link Between Bisphosphonates and Esophageal Cancer

Evidence is inconclusive on a possible association between the use of oral bisphosphonates and an increased risk for esophageal cancer, the FDA said Thursday. The agency added that there are "insufficient data" to recommend endoscopy for asymptomatic patients taking the drugs.

As part of its ongoing safety review, the FDA looked at two analyses from the U.K. General Practice Research Database: one study found no increase in risk with bisphosphonates, while the other found twice the risk for esophageal cancer in patients who filled at least 10 prescriptions or who used bisphosphonates for 3 or more years. The agency noted that other studies showed either no increase in risk or a reduced risk for esophageal cancer.

The FDA reminds providers that esophagitis has been observed in some bisphosphonate users, especially those not following package instructions. Accordingly, patients should be advised to follow the instructions carefully (e.g., they should not lie down for 30 to 60 minutes after taking the drugs).