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jueves, 9 de febrero de 2012

PPIs and CDAD


ROCKVILLE, Md -- February 8, 2012 -- The US Food and Drug Administration (FDA) has notified the public that: the use of proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrheal (CDAD).
A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhoea 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. The FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers.
Information for Healthcare Professionals: • A diagnosis of CDAD should be considered for PPI users with diarrhoea 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.htm
Download form 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
List of PPIs:
• rabeprazole sodium (AcipHex)
• dexlansoprazole (Dexilant)
• esomeprazole magnesium (Nexium)
• Over-the-counter omeprazole
• Over-the-counter lansoprazole (Prevacid and Prevacid 24hr)
• Omeprazole (Prilosec)
• pantoprazole sodium (Protonix)
• esomeprazole magnesium and naproxen (Vimovo)
• omeprazole and Sodium bicarbonate (Zegerid