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ARTICLE | Clinical News

AcipHex rabeprazole regulatory update

February 13, 2012 8:00 AM UTC

FDA issued a safety communication to warn that prescription and OTC proton pump inhibitors (PPI) may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD). The agency said a diagnosis of CDAD should be considered for those receiving PPIs with diarrhea that does not improve. FDA said that it is working with manufacturers to include the increased risk in PPI labels. The agency is also reviewing the risk of CDAD in patients receiving prescription and OTC histamine H2 receptor ( HRH2; H2R) blockers. Prescription PPIs and H2R blockers are indicated for gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus, while the OTC products are used for heartburn.

FDA identified the potential risk after a review of reports from its Adverse Events Reporting System (AERS), medical literature and 28 published observational studies, which showed that the risk of C. difficile infection or disease, including CDAD, was 1.4-2.75 times higher in patients with PPI exposure vs. those without PPI exposure. ...