Proton pump inhibitors: risk of bone fractures

Starting date:
April 4, 2013
Posting date:
April 4, 2013
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-26523

Issue

Health Canada is informing Canadians and Canadian health care professionals of the potential risk of bone fractures associated with the use of drugs known as proton pump inhibitors.

Proton pump inhibitors (PPIs) are drugs used to reduce stomach acid and are widely used to treat conditions such as acid reflux (heartburn) and stomach ulcers.

Several scientific studies suggest that PPI therapy may be associated with a small increased risk for fractures of the hip, wrist, or spine related to osteoporosis, a disease resulting in the weakening of bones. The risk of fracture was higher in patients who received multiple daily doses of PPIs and therapy for a year or longer. Additional risk factors for osteoporosis, such as age, gender and the presence of other health conditions, may also contribute to the increased risk of fractures.

At Health Canada’s request, manufacturers of all PPIs marketed in Canada have updated the drug labels for their products to include information on this risk.

Healthcare professionals should closely monitor patients with risk factors for osteoporosis who use PPIs, and report any adverse reactions to Health Canada.

Health professionals are also reminded that PPIs should be prescribed at the lowest dose and shortest duration of therapy appropriate to the condition being treated.

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).

What you should do

If you are taking PPIs and are at risk of osteoporosis, or are unsure of whether you are at risk, please consult your healthcare professional.
Health Canada has previously communicated with consumers and healthcare professionals regarding PPIs and an increased risk of Clostridium difficile-associated diarrhea, and potential interactions between PPIs and methotrexate and Plavix.

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.

Report health or safety concerns

  • Call toll-free at 1-866-234-2345
  • Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709