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PPIs possibly linked to C. difficile-associated diarrhea
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The FDA released a warning today that proton pump inhibitors may be associated with an increased risk for Clostridium difficile-associated diarrhea.
The agency is working with manufacturers to include information about the increased risk for Clostridium difficile-associated diarrhea (CDAD) with use of proton pump inhibitors (PPIs) in the drug labels, according to a press release.
The FDA is also reviewing the risk for CDAD in users of histamine H2-receptor blockers, which also are prescribed to treat gastroesophageal reflux disease, stomach and small intestine ulcers and heartburn.
According to the FDA, a diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve. Physicians should advise patients to seek immediate care if they experience persistent watery stools, abdominal pain and fever while taking PPIs. In addition, patients should be encouraged to use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.The following drugs are included in this warning:
- Dexlansoprazole (Dexilant, Takeda Pharmaceuticals)
- Esomeprazole magnesium (Nexium, AstraZeneca)
- Esomeprazole magnesium and naproxen (Vimovo, AstraZeneca)
- Lansoprazole (Prevacid, Takeda Pharmaceuticals) and over-the-counter Prevacid 24HR
- Omeprazole (Prilosec, AstraZeneca) and OTC
- Omeprazole and sodium bicarbonate (Zegerid, Merck) and OTC
- Pantoprazole sodium (Protonix, Pfizer)
- Rabeprazole sodium (AcipHex, Janssen Pharmaceuticals)
Physicians should report adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.
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