The United States Food and Drug Administration (U.S. FDA) has issued a safety communication in the U.S. notifying healthcare professionals and patients about its ongoing review of data from published studies to assess whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the oesophagus.

At the current 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 FDA review is ongoing and the FDA has not concluded that taking an oral bisphosphonate drug increases the risk of oesophageal cancer. There are insufficient data to recommend endoscopic screening of asymptomatic patients and 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. The FDA also stresses that oesophageal cancer is rare, especially in women.

Additional information is provided for patients and healthcare professionals – please see links below.