Impact of EMA regulatory label changes on systemic diclofenac initiation, discontinuation, and switching to other pain medicines in Scotland, England, Denmark, and The Netherlands.
Daniel R MoralesSteve V MorantThomas M MacDonaldIsla S MackenzieAlexander S F DoneyLyn MitchellMarion BennieChris RobertsonNina Sahlertz KristiansenJesper HallasMartin Thomsen ErnstLi WeiLizzie NicholsonCarole MorrisRon M C HeringsJetty A OverbeekElisabeth SmitsRobert W V FlynnPublished in: Pharmacoepidemiology and drug safety (2020)
The regulatory action was associated with significant reductions in overall diclofenac initiation which varied by country and type of exposure. There was no impact on discontinuation and variable impact on switching.