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Papers of the Week

2020 Mar

Pharmacoepidemiol Drug Saf



Impact of EMA regulatory label changes on systemic diclofenac initiation, discontinuation, and switching to other pain medicines in Scotland, England, Denmark, and The Netherlands.


Morales DR, Morant SV, MacDonald TM, Mackenzie IS, Doney ASF, Mitchell L, Bennie M, Robertson C, Hallas J, Pottegard A, Ernst M T, Wei L, Nicholson L, Morris C, M C R, Overbeek JA, Smits E, W V R
Pharmacoepidemiol Drug Saf. 2020 Mar; 29(3):296-305.
PMID: 31899936.


In 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.