Abstract
PurposeIn June 2013 a European Medicines Agency referral procedure concluded that diclofenac was associated with an elevated risk of acute cardiovascular events and contraindications, warnings, and changes to the product information were implemented across the European Union. This study measured the impact of the regulatory action on the prescribing of systemic diclofenac in Denmark, The Netherlands, England, and Scotland.MethodsQuarterly time series analyses measuring diclofenac prescription initiation, discontinuation and switching to other systemic nonsteroidal anti‐inflammatory (NSAIDs), topical NSAIDs, paracetamol, opioids, and other chronic pain medication in those who discontinued diclofenac. Absolute effects were estimated using interrupted time series regression.ResultsOverall, diclofenac prescription initiations fell during the observation periods of all countries. Compared with Denmark where there appeared to be a more limited effect, the regulatory action was associated with significant immediate reductions in diclofenac initiation in The Netherlands (−0.42%, 95% CI, −0.66% to −0.18%), England (−0.09%, 95% CI, −0.11% to −0.08%), and Scotland (−0.67%, 95% CI, −0.79% to −0.55%); and falling trends in diclofenac initiation in the Netherlands (−0.03%, 95% CI, −0.06% to −0.01% per quarter) and Scotland (−0.04%, 95% CI, −0.05% to −0.02% per quarter). There was no significant impact on diclofenac discontinuation in any country. The regulatory action was associated with modest differences in switching to other pain medicines following diclofenac discontinuation.ConclusionsThe 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.
Highlights
Adverse effects from medicines are common, and improving the safe use of medicines requires effective communication of new safety information
The quarterly prevalence of diclofenac initiation at the start and end of each data source follow-up ranged from 0.98% in Denmark to 2.47% in the Netherlands (Table S1)
The 2013 European Medicines Agency (EMA) regulatory action for diclofenac had a significant impact on diclofenac prescribing the magnitude and type of which varied between countries
Summary
Adverse effects from medicines are common, and improving the safe use of medicines requires effective communication of new safety information. Regulatory agencies such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) constantly evaluate the benefit and risk of a medicine and are responsible for alerting prescribers and patients to new safety information. The referral procedure concluded that for the benefitrisk balance of diclofenac to remain favourable, contraindications, warnings, and changes to the product information, including communication via a direct health care professional communication (DHPC) were required to be implemented across the European Union (EU)
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