Pharmacy Daily | Remove diclofenac from EML?

DICLOFENAC should be removed from national Essential Medicines Lists (EMLs) and its marketing authorisations should be revoked globally, according to research published in PLoS Medicine. The study looked at the extent to which evidence on cardiovascular risk with NSAIDs has translated into guidance and sales in 15 countries. In doing so the study took into account meta-analyses of randomised trials and controlled observational studies, and obtained the list of individual NSAIDs on Essential Medicines Lists from the World Health Organisation. In addition, NSAID sales or prescription data for 15 low-, middle-, and high-income countries was obtained from Intercontinental Medical Statistics Health (IMS Health) or (in the case of England and Canada) the national prescription pricing audit. According to the study findings, three drugs: rofecoxib, diclofenac, etoricoxib, were ranked consistently highest in terms of cardiovascular risk compared with nonuse, whilst naproxen was associated with a low risk. Interestingly diclofenac and etoricoxib accounted for one-third of total NSAID usage across the 15 countries, with diclofenac the most commonly used- taking an average market share of 30%, despite its higher relative risk of cardiovascular events. In contrast, researchers noted that naproxen, which was found to be one of the safest NSAIDs examined, was among the least popular and was listed on a minority of EMLs. “Listing of NSAIDs on national EMLs should take account of cardiovascular risk, with preference given to low risk drugs,” the researchers said. “Diclofenac has a risk very similar to rofecoxib, which was withdrawn from worldwide markets owing to cardiovascular toxicity. “Diclofenac should be removed from EMLs,” the researchers added. MEANWHILE ASMI has urged caution in interpreting the research results, noting that no new data on cardiovascular risk had been included in the analysis and, that the analysis did not segregate prescription and over-the-counter (OTC) NSAID data.

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