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The Indian Express
07 July 2013
New Delhi, India.

Prominent cardiologists have opposed the inclusion of a painkiller, Diclofenac, in the National List of Essential Medicines (NLEM) as against safer drugs like Naproxen.

Diclofenac is a non–steroidal anti–inflammatory drug (NSAID). Cattle used to be administered Diclofenac to reduce joint pain and keep them working for long hours. The flesh of such dead cattle have been found to be lethal for vultures. Of late, Diclofenac has been replaced by a drug that is less lethal to avian life. But despite this its use in humans is extensive.

Questioning the inclusion of Diclofenac in the NLEM, Dr Ambuj Roy of the cardiology department of AIIMS and Dr K S Reddy, president of Public Health Foundation of India, in an article in the online journal PLOS Medicine, say Naproxen, a cheaper option that is safe for the cardiovascular system, does not even feature in the list. Though Diclofenac is not in the WHO list, its sale is high compared to Naproxen across the world.

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Drugs like Diclofenac are often prescribed in patients of osteoarthritis and other such conditions. But such drugs increase risk of heart attack and stroke. "India exemplifies this disconnect between available evidence versus recommendations and practice. Diclofenac features in NLEM, while Naproxen does not. In 2008, the sales of Diclofenac were 11.3 times higher than Naproxen in financial terms and 9.4 times higher in terms of the number of tablets sold," Dr Reddy and Roy wrote in their perspective on an analysis by Australian, English and Canadian researchers on the trends in NSAID use. The survey was funded by the Harvey Research Institute and no external funding was received.

Though the researchers did not cover India, the analysis show that Diclofenac and Etoricoxib ranked high in cardiovascular risk. The two drugs accounted for one–third of total NSAID use in 15 countries. Diclofenac is listed in the NLEMs of 74 nations and Naproxen in just 27.

"With clear evidence of harmful health effects of Diclofenac, its inclusion in NLEM is unacceptable. It is important that scientific evidence must be regularly reviewed while choosing drugs for NLEM and for weeding out drugs with serious adverse effects," Dr Reddy said.

Some of these NSAIDS, when they first entered the scene in the 1990s, had generated a lot of enthusiasm as they did not have adverse gastrointestinal effect. But evidence of its cardiovascular risk has forced doctors to do a rethink. The list of essential medicines shows that public policy has barely kept pace. It also raises questions about the post–marketing surveillance of approved drugs.

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