Proton pump inhibitors (antacids): possible risk of Clostridium difficile-associated diarrhea

Starting date:
February 16, 2012
Posting date:
February 16, 2012
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Identification number:
RA-110005424

Health Canada is informing Canadians of a possible association between the use of prescription stomach antacids known as proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile-associated diarrhea (CDAD).

Clostridium difficile, commonly called C. difficile, is a bacterium that can cause diarrhea and may lead to more serious intestinal conditions. Healthy people are not usually vulnerable to C. difficile. Factors known to increase the risk of infection include advanced age, severe underlying illness, hospitalization, or antibiotic use.

PPIs reduce stomach acid and are widely used to treat conditions such as acid reflux, and stomach and small intestine ulcers. See below for a list of Proton Pump Inhibitors.

There have been a number of studies suggesting a possible link between PPIs and an increased risk of CDAD, particularly in vulnerable patients. Health Canada has been assessing this data on an ongoing basis.

The studies acknowledge important limitations with regards to study design and the impossibility of establishing a definite cause-and-effect relationship between PPIs and an increased risk of CDAD, as there are a number of other factors that may play a role.

While a definite association between PPI use and CDAD has not been confirmed, the possibility has not been ruled out at this time. The potential for an increased risk of C.difficile infection is identified in the Canadian labelling for PPI drugs. Health Canada will continue to monitor this issue, evaluate the scientific evidence as it emerges and take appropriate action as necessary.

Patients taking a PPI who develop a diarrhea that does not improve should speak to a healthcare professional immediately as this may be CDAD. Symptoms include severe watery or bloody diarrhea (at least three bowel movements per day for two or more days); fever; loss of appetite; nausea; and abdominal pain or tenderness.

Patients taking a PPI should talk with their doctor or pharmacist if they have questions or concerns about their antacid treatment.

Health professionals are reminded that PPIs should be prescribed at the lowest dose and shortest duration of therapy appropriate to the condition being treated. A diagnosis of CDAD should be considered for any patient who has risk factors for CDAD and who has persistent or severe diarrhea.

Drug labels, also known as "Product Monographs", contain important prescribing and safety information for health professionals and patients, and are available by search of Health Canada's Drug Product Database.

Proton Pump Inhibitors drugs currently marketed in Canada

The following proton pump inhibitors are available in Canada:

  • Dexlansoprazole (sold under the brand name Dexilant)
  • Esomeprazole (sold under the brand name Nexium and its generic equivalent)
  • Omeprazole (sold under the brand name Losec and its generic equivalents)
  • Lansoprazole (sold under the brand name Prevacid and its generic equivalents)
  • Pantoprazole (sold under the brand names Pantoloc and Panto IV, and their generic equivalent(s))
  • Pantoprazole/magnesium (sold under the brand name Tecta)
  • Rabeprazole (sold under the brand name Pariet and its generic equivalents)

PPIs are also available in combination with other drugs, for example: Vimovo (contains esomeprazole).

Report health or safety concerns

To report suspected adverse reaction (side effect) to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

Fax: 1-866-678-6789
Internet: MedEffect Canada
Mail (Get a postage-paid label): Canada Vigilance Postage Paid Label
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9

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