Researchers call for the withdrawal of diclofenac worldwide

New research pointing to the widespread use of diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that increases heart attack risk, has led researchers at the Institute for Clinical Evaluative Sciences (ICES) and the William Harvey Research Institute in London (UK) to call for its withdrawal from international markets. NSAIDs are widely used to relieve pain and inflammation. The researchers found that diclofenac is the most commonly used NSAID in fifteen countries worldwide despite carrying the same risk as Vioxx® (rofecoxib), a NSAID removed from the market in 2004 due to its heart attack risk. In contrast, the lowest risk NSAID, naproxen, is among the least-used.

“We are advocating the withdrawal of diclofenac worldwide. The inclusion of NSAIDs on influential national Essential Medicines Lists (EMLs) should take account of cardiovascular risk, with preference given to low risk drugs such as naproxen,” says David Henry, co-author of the study and CEO at ICES.

NSAIDs that have an elevated risk of cardiovascular events, particularly heart attacks, are widely used in low- and middle-income countries as well as in high-income countries.

Diclofenac is the most popular NSAID, despite its higher relative risk of cardiovascular events compared with other widely available NSAIDs. Diclofenac is recommended on most EMLs even though its cardiovascular risk information has been available for more than six years. Use of naproxen, the safest NSAID was low and it was included on a minority of EMLs. Etoricoxib, a relatively new NSAID that is available by prescription in the UK, is also associated with increased cardiovascular risk and was found to be popular in some countries.

The study found that:

• The two NSAIDs associated with the highest cardiovascular risks, diclofenac and etoricoxib, account for approximately one-third of all sales of NSAIDs in the 15 countries included in the study.
• The NSAID with the lowest cardiovascular risk, naproxen, accounted for less than 10 per cent of NSAID sales in these countries.

“These findings have significant implications for public health, particularly in low- and middle-income countries where cardiovascular disease is increasingly common and where huge efforts are now spent on trying to reduce risks. Essential Medicines Lists are authoritative influences on prescribing and on the selection of medicines for public subsidy. The continued inclusion of diclofenac on EMLs contributes unintentionally to cardiac risk in these countries,” said Patricia McGettigan, co-author of the study and clinical pharmacologist at the William Harvey Research Institute in London, UK.

Authors: Patricia McGettigan and David Henry.

The study “Use of non-steroidal anti-inflammatory drugs that elevate cardiovascular risk: an examination of sales and essential medicines lists in low-, middle-, and high-income countries,” was published today in PLoS Medicine.

ICES is an independent, non-profit organization that uses population-based health information to produce knowledge on a broad range of healthcare issues. Our unbiased evidence provides measures of health system performance, a clearer understanding of the shifting healthcare needs of Ontarians, and a stimulus for discussion of practical solutions to optimize scarce resources. ICES knowledge is highly regarded in Canada and abroad, and is widely used by government, hospitals, planners, and practitioners to make decisions about care delivery and to develop policy.

The William Harvey Research Institute (WHRI) at Barts and The London School of Medicine and Dentistry is the largest pharmacological research institute in the UK. It was founded in 1985 by Nobel Laureate Sir John Vane.

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