Impact of EU regulatory label changes for diclofenac in people with cardiovascular disease in four countries: Interrupted time series regression analysis.
Daniel R MoralesSteven V MorantThomas M MacDonaldNina Sahlertz KristiansenMartin Thomsen ErnstJesper HallasRon M C HeringsElisabeth SmitsJetty A OverbeekIsla S MackenzieAlexander S F DoneyLyn MitchellMarion BennieChris RobertsonLi WeiLizzie NicholsonCarole MorrisRobert W V FlynnPublished in: British journal of clinical pharmacology (2020)
Although significant reductions in diclofenac initiation occurred, patients with contraindications continued to be prescribed diclofenac, the extent of which varied by country and target condition. Understanding reasons for such variation may help to guide the design or dissemination of future safety warnings.