The Food and Drug Administration notified the public that the use of proton pump inhibitors may be associated with an increased risk of Clostridium difficile-associated diarrhea.
A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve, according to the FDA. Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.
PPIs, marketed under various brand and generic drug names, work by reducing the amount of acid in the stomach. Prescription PPIs (Dexilant, Nexium, Vimovo, Prevacid, Prilosec, Zegerid, Protonix and AcipHex) are used to treat conditions such as gastroesophageal reflux disease, stomach and small intestine ulcers and inflammation of the esophagus. Over-the-counter PPIs (Prevacid 24HR, Priolsec OTC, Zegerid OTC and Omeprazole) are used to treat frequent heartburn.
The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.
The FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers, used to treat conditions such as GERD, stomach and small intestine ulcers and heartburn. H2 receptor blockers are marketed under various brand and generic drug names as prescription (Tagamet, Pepcid, Duexis, Axid, Nizatidine, Zantac, Tritec) and OTC (Tagamet HB, Pepcid Complete, Pepcid AC, Axid AR, Zantac) products.
The FDA reviewed reports from its Adverse Event Reporting System and the medical literature for cases of CDAD in patients undergoing treatment with PPIs. Many of the adverse event reports involved patients who were elderly, had chronic and/or concomitant underlying medical conditions or were taking broad-spectrum antibiotics that could have predisposed them to developing CDAD.
Although these factors could have increased their risk of CDAD, according to the FDA, the role of PPI use cannot be definitively ruled out in the reviewed reports. Patients who have one or more of these risk factors may have serious outcomes from CDAD with concomitant PPI use.
The FDA also reviewed 28 observational studies in 26 publications. Twenty-three of the studies showed a higher risk of C. difficile infection or disease, including CDAD, associated with PPI exposure compared to no PPI exposure. Although the strength of the association varied widely from study to study, most studies found that the risk of C. difficile infection or disease, including CDAD, ranged from 1.4 to 2.75 times higher among patients with PPI exposure compared to those without PPI exposure. In the five studies that provided information on clinical outcomes, colectomies and, rarely, deaths were reported in some patients.
The published studies varied in their ability to assess the association between C. difficile infection or CDAD and prior PPI use. There were limited data on the relationship between the risk of C. difficile infection or CDAD and PPI dose and duration of use. There also was little information on the use of over-the-counter PPIs in community settings in these studies. Nevertheless, according to the FDA, the weight of evidence suggested a positive association between the use of PPIs and C. difficile infection and disease, including CDAD.
According to the FDA, healthcare professionals should advise patients to seek immediate professional care if they experience watery stool that does not go away, abdominal pain and fever while taking PPIs. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Healthcare professionals can report adverse events involving PPIs to the FDA MedWatch program at http://1.usa.gov/bW5WC.
A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve, according to the FDA. Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.
PPIs, marketed under various brand and generic drug names, work by reducing the amount of acid in the stomach. Prescription PPIs (Dexilant, Nexium, Vimovo, Prevacid, Prilosec, Zegerid, Protonix and AcipHex) are used to treat conditions such as gastroesophageal reflux disease, stomach and small intestine ulcers and inflammation of the esophagus. Over-the-counter PPIs (Prevacid 24HR, Priolsec OTC, Zegerid OTC and Omeprazole) are used to treat frequent heartburn.
The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.
The FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers, used to treat conditions such as GERD, stomach and small intestine ulcers and heartburn. H2 receptor blockers are marketed under various brand and generic drug names as prescription (Tagamet, Pepcid, Duexis, Axid, Nizatidine, Zantac, Tritec) and OTC (Tagamet HB, Pepcid Complete, Pepcid AC, Axid AR, Zantac) products.
The FDA reviewed reports from its Adverse Event Reporting System and the medical literature for cases of CDAD in patients undergoing treatment with PPIs. Many of the adverse event reports involved patients who were elderly, had chronic and/or concomitant underlying medical conditions or were taking broad-spectrum antibiotics that could have predisposed them to developing CDAD.
Although these factors could have increased their risk of CDAD, according to the FDA, the role of PPI use cannot be definitively ruled out in the reviewed reports. Patients who have one or more of these risk factors may have serious outcomes from CDAD with concomitant PPI use.
The FDA also reviewed 28 observational studies in 26 publications. Twenty-three of the studies showed a higher risk of C. difficile infection or disease, including CDAD, associated with PPI exposure compared to no PPI exposure. Although the strength of the association varied widely from study to study, most studies found that the risk of C. difficile infection or disease, including CDAD, ranged from 1.4 to 2.75 times higher among patients with PPI exposure compared to those without PPI exposure. In the five studies that provided information on clinical outcomes, colectomies and, rarely, deaths were reported in some patients.
The published studies varied in their ability to assess the association between C. difficile infection or CDAD and prior PPI use. There were limited data on the relationship between the risk of C. difficile infection or CDAD and PPI dose and duration of use. There also was little information on the use of over-the-counter PPIs in community settings in these studies. Nevertheless, according to the FDA, the weight of evidence suggested a positive association between the use of PPIs and C. difficile infection and disease, including CDAD.
According to the FDA, healthcare professionals should advise patients to seek immediate professional care if they experience watery stool that does not go away, abdominal pain and fever while taking PPIs. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Healthcare professionals can report adverse events involving PPIs to the FDA MedWatch program at http://1.usa.gov/bW5WC.
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