FDA Issues Warning On Proton Pump Inhibitors (PPIs)
The FDA warned that the use of s
The FDA warned that the use of stomach acid drugs known as proton pump
inhibitors (PPIs) may be associated
with an increase risk of Clostridium difficile-associated diarrhea (CDAD).
PPIs suppress stomach acid which
may help protect against infection causing
such as Clostridium difficile.
(Note: Infection is most often
related to the use of antibiotics during healthcare treatment).
The FDA, in a
said that “Patients should immediately
contact their healthcare professional and seek care if they take PPIs and
develop diarrhea that does not improve”. The
statement also said that patients should not stop taking the medicines without
first consulting their physician.
Health care providers and patients alike should be aware that this warning stems
from a review of data from the FDA’s Adverse Event Reporting System, as well as
medical literature, that suggests a positive association between the use of PPIs
and CDAD—causality has not been
A recent study showing
an association was a meta-analysis of 21 published studies totaling 133,054
patients hospitalized on general medicine services.
that none of the included studies was a randomized trial, that results were
inconsistent and that data were not available on other risk factors for C.
difficile, or type, dose, or duration of PPI use.
Patients should use the lowest dose and shortest duration of PPI therapy
appropriate to the condition being treated.
Indiscriminate use of PPIs should be discouraged.
PPIs have not been proven to increase the risk of C. difficile;
they have been shown to be associated with an increased risk of C. difficile.
For more talking points for
providers and patients visit the FDA’s website or click