Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools.
Rachel E SobelAndrew BateJames MarshallKevin HaynesNandini SelvamVinit NairGregory DanielJeffrey S BrownRobert F ReynoldsPublished in: Pharmacoepidemiology and drug safety (2018)
This analysis demonstrated the ability to use Sentinel tools to assess the effectiveness of a label change and accompanying communication at the population level and suggests an influence on subsequent dispensing behavior.