Canadian Association of Gastroenterology Position Statement: Hip Fracture and Proton Pump Inhibitor Therapy – a 2013 Update

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Health Canada recently provided an information update on proton pump inhibitor (PPI) therapy and risk of fracture in April 2013 (1) stating “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.” The Canadian Association of Gastroenterology (CAG) provided a position statement on PPI therapy and risk of hip fracture in 2008 (2) and we have updated this in light of the recent Health Canada statement. Large administrative databases are a useful tool to assess possible benefit or harms of health care interventions; however, given that billions of associations can be measured with these databases, highly statistically significant findings will inevitably occur by chance. Added to this problem is that any association may simply be due to confounding factors and not due to the health care intervention causing the disease (eg, a database study may find that steroid inhaler therapy increases the risk of lung cancer but this may simply be due to smokers being more likely to have lung disease [and be given steroid inhalers] and smoking causes lung cancer). Associations between health care interventions and risk of harm are, therefore, being reported almost every week and it is, therefore, very difficult for the clinician to know what associations are likely to be causal and what are likely to be spurious. There is no simple answer to this problem because epidemiological data can never prove or disprove a hypothesis. Hill (3) described nine factors that make an association more likely to be causal. We have previously evaluated the evidence for PPI therapy and risk of fracture according to the most important of these factors, namely, strength of the association, biological plausibility, specificity, consistency of the association and evidence of a dose response relationship (4). We have conducted an updated systematic review evaluating PPI therapy and risk of fracture that will be submitted to a peer reviewed journal and have used these data to assess the CAG’s position on the use of PPI therapy and risk of fracture.