The FDA warned that proton-pump inhibitors (PPIs) can trigger the development of Clostridium difficile-associated diarrhea (CDAD). The agency is working with manufacturers of the stomach acid drugs to include information in the labels about the increased risk.
US regulators examined the Adverse Event Reporting System for reports of CDAD associated with the drugs, as well as 28 observational studies. While the strength of the association varied widely between studies, the agency concluded that "the weight of evidence suggests a positive association between the use of PPIs and C. difficile infection and disease." Specifically, the FDA said that studies showed that using the drugs may raise the risk of C. difficile infection or disease, including CDAD, by between 1.4 and 2.75 times.
The FDA also said it is reviewing whether histamine H2 receptor blockers can also trigger the illness