Proton Pump Inhibitors (PPIs)
February 9, 2012
FDA is alerting healthcare professionals and consumers of a potentially increased risk of Clostridium difficile-associated diarrhea (CDAD) in patients taking proton pump inhibitors (PPIs). Proton pump inhibitors include the following over the counter and prescription products: dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole. Advise patients taking a PPI to seek immediate medical care if they develop diarrhea that does not improve over time. Consider CDAD in the differential diagnosis of these patients. FDA is working with manufacturers to include a warning about CDAD in the product labeling for the PPIs. FDA is currently examining the risk of CDAD with H2 receptor blockers (eg, famotidine, ranitidine).
The potential risk of CDAD during PPI treatment was identified in the FDA Adverse Event Reporting System (AERS) and in observational trials. Many of the patients discussed in AERS were elderly, taking broad spectrum antibiotics, or had other chronic medical conditions that put them at increased risk of developing CDAD. The risk of CDAD was higher for patients taking PPIs than control in 23 of 28 observational studies.
Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
February 9, 2012. University of Utah Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.