Proton Pump Inhibitors and the Risk for Fracture at Specific Sites: Data Mining of the FDA Adverse Event Reporting System.

An increasing trend was observed for the reporting of fractures with PPI use and its percentage among all PPI-associated ADEs, especially after 2010 when the FDA black box warning was issued (Fig. 1 ).

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While the signal for the drug class-ADE class HLT ‘upper limb fractures’ did not reach statistical significance (PRR = 1.8), several PT fracture sites under this category either did show a signal or had a PRR that approached a statistically significant signal, including for the PT ‘wrist fracture’ (PRR = 1.9).

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