Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

ConclusionsThis 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.

Source: Pharmacoepidemiology and Drug Safety - January 1, 2018 Category: Drugs & Pharmacology Authors: Rachel E. Sobel, Andrew Bate, James Marshall, Kevin Haynes, Nandini Selvam, Vinit Nair, Gregory Daniel, Jeffrey S. Brown, Robert F. Reynolds Tags: ORIGINAL REPORT Source Type: research