FDA: Not enough data to link osteoporosis drugs and esophageal cancer

July 28, 2011

Insufficient information exists from which to draw a conclusion that women who take bisphosphonates to prevent or treat osteoporosis are at increased risk of cancer of the esophagus, the United States Food and Drug Administration (FDA) reports in a recent Drug Safety Communication (July 21, 2011). The FDA doesn?t recommend endoscopic screening of asymptomatic patients at this time.

Insufficient information exists from which to draw a conclusion that women who take bisphosphonates to prevent or treat osteoporosis are at increased risk of cancer of the esophagus, the United States Food and Drug Administration (FDA) reports in a recent Drug Safety Communication (July 21, 2011). The FDA doesn’t recommend endoscopic screening of asymptomatic patients at this time.

The agency does recommend that patients discuss the benefits and risks of taking oral bisphosphonates-including alendronate (Fosamax), risedronate (Actonel), ibandronate (Boniva), risedronate delayed release (Atelvia), etidronate (Didronel), and tiludronate (Skelid)-and duration of therapy with their healthcare professional. Patients should also notify their healtcare provider if they develop swallowing difficulties, chest pain, new or worsening heartburn, or pain with swallowing.

Healthcare professionals should instruct patients to follow carefully the directions for using oral bisphosphonates. The FDA encourages both professionals and patients to report adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program (www.fda.gov/MedWatch/report.htm). Esophagitis and other esophageal events have been described, especially among patients who don’t follow the directions for taking the drugs.

Studies evaluating the risk of esophageal cancer have produced conflicting findings. The FDA will continue to evaluate data on the safety and effectiveness of bisphosphonate drugs and will issue updates when more information becomes available.