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U.S. Department of Health and Human Services

Safety

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Proton Pump Inhibitor (PPI) Drugs

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2012

Summary View

Added:

Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension
Zegerid (omeprazole/sodium bicarbonate) Capsules

 

October 2012

Summary View

 

 

September 2012

Summary View

  • Aciphex (rabeprazole sodium) Delayed-Release Tablets
  • Dexilant (dexlansoprazole) Delayed-Release Capsules
  • Prevacid (lansoprazole) Delayed-Release Capsules, and Delayed-Release Orally Disintegrating Tablets
  • Prilosec (omeprazole) Delayed-Release Capsules, Delayed-Release Oral Suspension
  • Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension
  • Protonix (pantoprazole sodium) Delayed-Release Tablets
  • Protonix (pantoprazole sodium) For Injection
  • Nexium (esomeprazole magnesium) Delayed-Release Capsules, Delayed-Release Oral Suspension
  • Nexium I.V. (esomeprazole sodium) For Injection
  • Vimovo (naproxen/esomeprazole magnesium) Delayed Release Tablets

 


To view current Prescribing Information, enter drug name in Drugs@FDA


 

5 WARNINGS AND PRECAUTIONS

5.x Clostridium difficile Associated Diarrhea
  • Published observational studies suggest that proton pump inhibitor (PPI) therapy like xxxxx may be associated with an increased risk of Clostridium difficile associated diarrhea (CDAD), especially in hospitalized  patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.x)].

    Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

    CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with xxxxx, refer to WARNINGS and PRECAUTIONS sections of those package inserts.