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Safety review of oral bisphosphonates continues

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According to a statement released today, the FDA will continue to review data from published studies to evaluate whether use of oral bisphosphonates is associated with an increased risk for esophageal cancer. There have been conflicting findings from studies evaluating this risk.

At this time, “the FDA believes that the benefits of oral bisphosphonates in reducing the risk for serious fractures in people with osteoporosis continue to outweigh potential risks,” according to the agency statement. The FDA’s review is ongoing and the agency has not concluded that patients taking oral bisphosphonates are at increased risk for esophageal cancer.

A case series published in January 2009 described reports submitted to the FDA of esophageal cancer in patients taking oral bisphosphonates. Since then, several epidemiological studies evaluating the association have been published, yielding discrepant findings. The largest studies reviewed thus far are two epidemiologic studies using the UK General Practice Research Database. One study found no increase in esophageal cancer risk with oral bisphosphonates. The second study found a doubling of the risk among patients who had 10 or more prescriptions of the drug or had taken the drug for longer than 3 years. Other studies using different patient databases have reported no increase in risk or a reduced risk, according to the FDA.

Commonly used oral bisphosphonates include alendronate (Fosamax, Merck), risedronate (Actonel, Warner Chilcott), risedronate delayed release (Atelvia, Warner Chilcott), ibandronate (Boniva, Roche), etidronate (Didronel, Proctor & Gamble) and tiludronate (Skelid, Sanofi Aventis).

Health care providers are encouraged to discuss with patients the benefits and risks of taking oral bisphosphonates and to instruct patients to carefully follow directions on the bisphosphonate they are prescribed. Adverse events involving these drugs should be reported to the FDA’s MedWatch program.

The FDA will continue to evaluate all available data supporting the safety and effectiveness of oral bisphosphonates and will update the public when more information becomes available, according to the statement.

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