Drug Review on PPIs – Proton Pump Inhibitors (Antacids) with Risk of CDAD – Clostridium Difficile Associated Diarrhea

The FDA is alerting gastroenerologists, general family practitioners and consumers on findings of the drug review for PPIs – Proton Pump Inhibitors, as well as H2RAs – Histamine H2 Receptor Antagonists which have elicited, or are under review, for the enhanced health risk of CDAD – Clostridium Difficile Associated Diarrhea.

FDA Alert on Stomach Acid Drugs (Antacids)

The FDA has established health risks associated with the use of common PPIs and has in turn communicated the drug safety information to the medical fraternity and consumers as well.

There are two categories of stomach acid drugs that the FDA has raised concerns with:

1.   Proton Pump Inhibitors (PPIs)
very effective in sustained reduction of stomach acids

2.   Histamine H2 Receptor Antagonists (H2RAs)
also known as H2 Receptor Blockers

Following FDA reviews on various different Proton Pump Inhibitors, the risk of developing CDAD – Clostridium Difficile Associated Diarrhea has been identified.

H2RAs or Histamine H2 receptor blockers are also under review as they are also possibly linked to the development of CDAD in persons using them.

Background of PPIs and H2RAs

PPIs or Proton Pump Inhibitors are stomach acid drugs (antacids) that are available both via prescription and also as OTC drugs (over-the-counter). They have since taken precedence over H2RAs or Histamine H2 Receptor Antagonists in the category of antacids.

Below are some of the facts highlighting the background of:

1. Proton Pump Inhibitors:

• they are used to treat stomach acidity
• they reduce acid levels and production of gastric acids in the stomach
• PPIs are indicated for the treatment of the following medical conditions:

recurrent heartburn
stomach ulcers (peptic ulcers – PUD/Peptic Ulcer Disease, duodenal ulcers, gastric ulcers)
intestinal ulcers (duodenal ulcers)
GERD (Gastroesophageal Reflux Disease)
esophageal inflammation such as in esophagitis, erosive esophagitis

2. Histamine H2 Receptor Antagonists

• they reduce stomach acidity
• this is by inhibiting histamine action on stomach cells that produce gastric acids
• they are less effective than Proton Pump Inhibitors
• H2RAs are indicated for the treatment of the following medical conditions:

heartburn
stomach ulcers (peptic ulcers – PUD/Peptic Ulcer Disease, duodenal ulcers, gastric ulcers)
intestinal ulcers (duodenal ulcers)
GERD – Gastroesophageal Reflux Disease
Dyspepsia (indigestion)

A comprehensive list of all the indicated drugs subject for review by the FDA is provided below.

Indicated stomach acid drugs under medical review

dexlansoprazole – Dexilant (prescription)
esomeprazole magnesium – Nexium (precription)
esomeprazole magnesium, naproxen – Vimovo (prescription)
lansoprazole – Prevacid (over-the-counter)
omeprazole – Omeprazole (over-the-counter)
omeprazole – Prilosec (over-the-counter)
omeprazole, Sodium bicarbonate – Zegerid (over-the-counter)
pantoprazole sodium – Protonix (prescription)
rabeprazole sodium – AcipHex (prescription

Background of CDAD – Clostridium Difficile Associated Diarrhea

Clostridium Difficile Associated Diarrhea (CDAD) is caused by the bacteria C. difficile (Clostridium difficile) which manifests as diarrhea that does not subside.

In persons already under treatment for stomach acidity with PPIs or H2RAs, the occurrence of CDAD manifests in just the same way.

Symptoms of Clostridium Difficile Associated Diarrhea (CDAD) include:

• abdominal pain
• very loose watery stool
• fever
• adverse intestinal problems

CDAD is also seen to spread rapidly within the hospital environment.

FDA Recommendation

Below is the official recommendation of the FDA:

” 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. “

Contacting the FDA to report cases relating to stomach acid drugs

Any adverse side effects or incidences relating to the use of Proton Pump Inhibitors (PPIs) and Histamine H2 Receptor Blockers (H2RAs) should immediately be reported to the FDA.
This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:

• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at:http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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