SAFETY ALERT: Bisphosphonates May Increase Esophageal Cancer Risk

The FDA has notified healthcare professionals that it is performing a review of data from published studies to evaluate if oral bisphosphonate drugs are associated with an increased risk of cancer of the esophagus. The FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer.  At this time, the 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.

The largest studies that the 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.

There are insufficient data to recommend endoscopic screening of asymptomatic patients. The 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.

Oral bisphosphonates are indicated in the prevention and treatment of osteoporosis, as well as to treat other bone diseases (eg, Paget's Disease). These agents include Actonel (risedronate; Warner Chilcott), Atelvia (risedronate delayed-release; Warner Chilcott), Boniva (ibandronate; Roche), Didronel (etidronate; Warner Chilcott), and Fosamax (alendronate; Merck).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264087.htm.