FDA Drug Safety Communication

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FDA Date: 7/21/11

Bisphosphonates FDA Drug Safety Communication

Ongoing Safety Review of Oral Osteoporosis Drugs (bisphosphonates) and Potential Increased Risk of Esophageal Cancer

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.

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.

-FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer and there are conflicting data on this risk.

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

-Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates.

- Instruct patients to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed.

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.

View the full FDA Drug Safety Communication on FDA.gov