FDA Says Proton Pump Inhibitors May Cause C-difficile Diarrhea

Using popular heartburn drugs called proton pump inhibitors (PPIs) could put some users at risk of contracting Clostridium difficile–associated diarrhea (CDAD), a potentially serious gastrointestinal infection. In a Drug Safety Communication issued yesterday, the U.S. Food & Drug Administration (FDA) said it is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

According to the U.S. Centers for Disease Control (CDC), Clostridium difficile (C. diff) is a bacterium that causes diarrhea that does not improve (CDAD), and more serious intestinal conditions such as pseudomembranous colitis. C. diff infection, which is often spread in hospitals, can pass from person-to-¬person on contaminated equipment and on the hands of doctors, nurses, other healthcare providers and visitors. While antibiotics can be used to treat C. diff, a patient might require surgery to remove the infected part of the intestines in the most severe cases.

PPIs are sold under the names:

• Dexilant (dexlansoprazole)
• Nexium (esomeprazole magnesium)
• Prevacid (lansoprazole) and OTC Prevacid 24hr
• Prilosec (omeprazole) and Prilosec OTC
• Protonix (pantoprazole sodium)
• Vimovo (esomeprazole magnesium and naproxen)
• Zegerid (omeprazole and Sodium bicarbonate) and Zegerid OTC

Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.

According to the FDA’s Drug Safety Communication, the agency said it had reviewed reports from its Adverse Event Reporting System (AERS) and the medical literature for cases of CDAD in patients treated with PPIs. Many of the reports reviewed 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. While those conditions can increase the risk of CDAD, the role of PPI use in the reports cannot be definitively ruled out, the agency said.

Twenty-three of the of 28 studies reviewed by the FDA also showed a higher risk of C. difficile infection or disease, including CDAD, associated with PPI exposure compared to no PPI exposure, the FDA said.

The FDA is advising healthcare providers to consider a diagnosis of CDAD for patients taking PPIs who have diarrhea that does not go away. As a precaution, patients should take the lowest dose of a PPI for the shortest duration that is appropriate for the condition being treated. Patients should seek care immediately if they develop diarrhea that does not improve.

The FDA also said it is also reviewing the risk of CDAD in users of histamine H2 receptor blockers, another class of drugs used to treat GERD, stomach and small intestine ulcers, and heartburn. H2 receptor blockers include the prescription drugs Tagamet, Tagamet HB, Pepcid, Pepcid Complete, Pepcid AC, Axid, Axid AR, Nizatidine, Zantac, and Tritec. The agency said it will communicate any new information on PPIs or H2 receptor blockers and the risk of CDAD when it becomes available.

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