Abstract
Proton pump inhibitors (PPIs) are widely used to treat gastric acid-related disorders. Concerns have been raised about potential fracture risk, especially at the hip, spine and wrist. However, fracture risk at other bone sites has not been as well studied. We investigated the association between PPIs and specific fracture sites using an aggregated knowledge-enhanced database, the Food and Drug Administration Adverse Event Reporting System Data Mining Set (AERS-DM). Proportional reporting ratio (PRR) was used to detect statistically significant associations (signals) between PPIs and fractures. We analyzed both high level terms (HLT) and preferred terms (PT) for fracture sites, defined by MedDRA (Medical Dictionary for Regulatory Activities). Of PPI users reporting fractures, the mean age was 65.3 years and the female to male ratio was 3.4:1. Results revealed signals at multiple HLT and PT fracture sites, consistent for both sexes. These included fracture sites with predominant trabecular bone, not previously reported as being associated with PPIs, such as ‘rib fractures’, where signals were detected for overall PPIs as well as for each of 5 generic ingredients (insufficient data for dexlansoprazole). Based on data mining from AERS-DM, PPI use appears to be associated with an increased risk for fractures at multiple sites.
Highlights
Proton pump inhibitors (PPIs) are acid suppressive agents used for managing gastric acid-related disorders, such as gastroesophageal reflux disease and peptic ulcers[1,2,3]
An increasing trend was observed for the reporting of fractures with PPI use and its percentage among all PPI-associated adverse drug events (ADEs), especially after 2010 when the Food and Drug Administration (FDA) black box warning was issued (Fig. 1)
The current study reveals associations between PPI use and multiple different sites of fractures based on data mining from Adverse Event Reporting System Data Mining Set (AERS-DM)
Summary
Proton pump inhibitors (PPIs) are acid suppressive agents used for managing gastric acid-related disorders, such as gastroesophageal reflux disease and peptic ulcers[1,2,3]. Concerns have been raised about potential adverse drug events (ADEs) associated with chronic PPI use, including fractures, hypomagnesaemia, interstitial nephritis, iron and vitamin B12 malabsorption, and infections[8]. Among these ADEs, fractures have received increasing attention since 2006 when Vestergaard et al.[9] and Yang et al.[10] reported that PPI use was associated with an increased risk of fractures, at the proximal femur (hip)[9, 10] and spine[9]. One paper focusing on fractures in hepatitis patients using PPIs did list specific fracture sites, only the association with overall fracture risk was reported[26]
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