美国FDA安全性信息：质子泵抑制剂（PPI）可致艰难梭菌相关性腹泻

Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridium Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs

AcipHex (rabeprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole magnesium) Omeprazole (omeprazole) Over-the-Counter (OTC) Prevacid (lansoprazole) and OTC Prevacid 24hr Prilosec (omeprazole) and OTC Protonix (pantoprazole sodium) Vimovo (esomeprazole magnesium and naproxen) Zegerid (omeprazole and Sodium bicarbonate) and OTC

[Posted 02/08/2012]

AUDIENCE: Gastroenerology, Family Practice, Consumer

ISSUE: FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.

BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. 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.