Drug Safety and Availability > FDA Drug Safety Communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer

The U.S. Food and Drug Administration (FDA) is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus (esophageal cancer). There have been conflicting findings from studies evaluating this risk.

At this time, FDA believes that the benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks.

FDA's review is ongoing and the Agency has not concluded that patients taking oral bisphosphonate drugs have an increased risk of esophageal cancer. It is also important to note that esophageal cancer is rare, especially in women.

The largest studies that FDA has reviewed, thus far, are two epidemiologic studies using one patient database (the U.K. General Practice Research Database or GPRD). One study found no increase in the risk of esophageal cancer. The second study found a doubling of the risk of esophageal cancer among patients who had 10 or more prescriptions of the drugs, or who had taken the drugs over 3 years. Other external researchers investigating this issue, using different patient databases, have reported no increase in risk, or a reduced risk. [Data summary available at link below]

Patients should talk with their healthcare professionals about the benefits and risks of taking oral bisphosphonates. Patients who take oral bisphosphonates should pay particular attention to the directions for use to minimize any potential adverse events.

FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available.

For more information, please visit: bisphosphonates ►
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