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  • FDA Date: 05/25/2010

    Aciphex (rabeprazole sodium) FDA Drug Safety Communication

    Possible Increased Risk of Fractures of the Hip, Wrist, and Spine with the Use of Proton Pump Inhibitors

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is revising the prescription and over-the-counter (OTC) labels for a class of drugs called proton pump inhibitors (PPIs) to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

    PPIs work by reducing the amount of acid in the stomach. Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold over-the-counter (OTC) for the treatment of frequent heartburn.

    The new safety information is based on FDA's review of several epidemiological studies, some of which found that those at greatest risk for these fractures received high doses of PPIs or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older, and the increased risk of fracture primarily was observed in this age group.

    Healthcare professionals and users of PPIs should be aware of the possible increased risk of fractures of the hip, wrist, and spine with the use of these drugs, weigh the known benefits against the potential risks when deciding to use them, and follow recommendations in the product labeling when prescribing PPIs.

    The data suggest that the increased risk may be dependent upon dose, duration of use, or both. At the present time, there is uncertainty about the magnitude of this risk. In light of this uncertainty, when prescribing PPIs, healthcare professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

    View the full FDA Drug Safety Communication on FDA.gov