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FDA Issued Warning on Several Proton Pump Inhibitors

logo of the United States Food and Drug Administration

On 8th February 2012, the US-FDA issued a new warning on several popular proton pump inhibitors (PPI).

The agency warned that the use of certain heartburn and acid reflux drugs might increase the risk of Clostridium difficile-associated diarrhea (CDAD.

The agency also suggested considering a diagnosis of CDAD for patients taking PPIs who developed diarrhea that does not improve.

The FDA issued this safety announcement just after the review of reports from the AERS (Adverse Event Reporting System) and the medical literature suggested such a link with PPIs.

According to the FDA's website, the warning applies to the following both prescription and over-the-counter PPIs:

  1. Omeprazole
  2. Omeprazole and sodium bicarbonate
  3. Esomeprazole magnesium
  4. Pantoprazole sodium
  5. Rabeprazole sodium
  6. Lansoprazole
  7. Dexlansoprazole

PPIs have been linked to several other adverse events, including arrhythmias, seizures, clopidogrel resistance, osteoporotic fractures, cardiac birth defects, and leg spasms.

The FDA safety announcement also reported that the agency has already started working with these drug manufacturers for modifying the labels to include the warning regarding increased risk of Clostridium difficile-associated diarrhea.

Quick Note

Clostridium difficile (C. difficile) is a bacterium, which causes a serious diarrhea that rarely improve. Its symptoms Include:

  • Water like stool
  • Serious intestinal discomforts
  • Pain in abdomen and fever

Update: Ongoing Research and Potential Risks of Taking PPIs

Since the initial warning in 2012, many studies have so far investigated the relationship between PPIs and CDAD risk. The results of these studies are mixed:

  • Some studies confirm the association
  • Others find no significant link

No doubt, the ongoing research is helping us to better understand the risks associated with PPIs. But we still need to do more research to fully recognize the dangers of taking PPIs.

Additional Risks Associated with PPIs

In addition to the CDAD risk, long-term use of PPIs has been linked to other potential adverse effects:

  • Increased risk of kidney disease
  • Osteoporosis-related fractures
  • Vitamin B12 deficiency

Healthcare providers are advised to regularly reassess patients using PPIs for an extended period and consider whether the therapy remains necessary or if the dosage can be reduced.

FDA Monitoring and Recommendations

The FDA continues to monitor the safety of PPIs and has issued additional updates and recommendations concerning their use. Patients taking PPIs are encouraged to:

  • Discuss any concerns with their healthcare providers
  • Not discontinue the medication without consulting a medical professional

Source: US Food and Drug Administration. FDA drug safety communication: Clostridium difficile–associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs). Silver Spring, MD: US Food and Drug Administration. 2012.

⚠️ Disclaimer: The information provided in this article is for educational purposes only and should not be considered as medical advice. Please consult a healthcare professional for personalized advice.