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U.S. Food and Drug Administration officials have announced that osteoporosis drugs, bisphosphonates, like the Merck's popular Fosamax, Procter & Gamble's Actonel or risedronate and Didronel or etidronate and Roche's Boniva or ibandronate may carry a risk for esophageal cancer.

Diane Wysowski of the Food and Drug Administration's (FDA) division of risk assessment called for research on the potential links between the bisphosphonates and cancer.

She reported that since the initial marketing of Fosamax, known generically as alendronate, in 1995, the FDA has received 23 reports in which patients developed esophageal tumors where the typical time lapse was two years between the first administration of the drug and the development of esophageal tumors. Out of 23 reported cases, eight patients died.

An already known side effect of bisphosphonate is esophagitis, an inflammation of the esophagus. This is why patients are instructed to remain upright for at least a half hour after taking the drugs.

One particular warning was issued to doctors about prescribing bisphosphonates to patients with Barrett's esophagus, which is a change in the lining that leads to the stomach. It is often found in people with acid reflux disease and itself increases the risk of cancer.

The FDA also said there were other conflicting findings about these drugs in other studies and that they were considering conducting further studies to investigate if the risk were feasible. In November the FDA said clinical trial data showed no overall risk of heart rhythm problems in patients taking bisphosphonates.

An estimated 10 million Americans, mostly women, have osteoporosis. Bisphosphonates aim to treat bone-weakening osteoporosis by increasing bone mass.


I think osteoporosis patients taking bisphosphonates should be warned by their doctors concerning the increased risk for esophageal cancer. I don't think this is routinely done.