美国FDA安全性信息：质子泵抑制剂(PPI)可致艰难梭(2)

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.

RECOMMENDATION: Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Information for Healthcare Professionals:

A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.

Advise patients to seek immediate care from a healthcare

professional 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 and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1

2 or call 1-800-332-1088 to request a reporting form,

then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/08/2012 - Drug Safety Communication3 - FDA]