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FDA Alert: Labeling Changes for PPIs

Pharmacist putting label on prescription bottle
RefluxMD Staff's picture
by RefluxMD Staff October 23, 2012

The FDA has updated the safety labeling requirements for several PPIs according to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. 

Labels Must Warn of Risk of C. difficile Associated Diarrhea

The labels for these medications will now include a statement warning of the risk of Clostridium difficile Associated Diarrhea (CDAD) since published observational studies suggest that PPI therapy may be associated with an increased risk of CDAD, especially in hospitalized patients. The label will also warn that patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Affected Medications

This requirement applies to the following PPIs:

  • 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 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

If you are taking PPIs, it is important that you understand the risks associated with them and be sure to talk to you doctor if you have any concerns.

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