[india-drug] Toxicity of nimesulide

["J.S. Bapna" <jbapna@iihmr.org>]

Toxicity of nimesulide
----------------------

I am surprised about the alarm raised by Sanjay Kumar regarding the 
toxicity of nimesulide. It must be made clear that there is no drug
that does not cause adverse effects. One has to weigh the risks versus
benefits for use of medicines.

As per the 'evidenced based' scientific literature, nimesulide appears 
to be the safest pain reliever. It was first marketed in Italy in the
early eighties by Roche and in India in 1994 and since then during
these two decades as per the WHO (October 2002) there are only 206
reports on varying degree of adverse effects on liver in contrast to
paracetamol with which 26,000 hospitalizations and 450 deaths occur in
USA per year due to hepatotoxicity (BMJ Sept 2002). If we go by his
ideas, all drugs will  be banned. In India nimesulide sales is in
excess of Rs 200 Crore (Rs 2 billion) annually. With an extensive use
as evident from its sales, the adverse effect can be considered
negligible or less than any of the pain relievers.

It is unfortunate that like many other drugs in India, Nimeusulide has 
been wrongly promoted in combination with other drugs. These
combinations are promoted by the manufacturers with an idea of
providing greater relief due to a broad spectrum of coverage. However,
this is far from being true. Most of these pain relievers act through a
common mechanism i.e., reduction of prostaglandin   (the pain producing
chemical) formation in the body by inhibiting the enzyme
cyclo-oxygenase (COX). On the contrary the chances of toxic effects on
stomach, liver and kidneys are enhanced due to exposure to more drugs
and invariably it is difficult to know as to which these or 
all of them are the culprit. Our own observation is that in a majority
of cases while prescribing and dispensing these pain relievers most of
the doctors as well as the pharmacists do not have any idea about the
constituents of the drugs in each of the brands.

These appears to be a lot of propaganda about the toxicity of existing 
drugs to promote expensive newer drugs . Similar is the case of
insecticides and host of other items. I do not think that we should be
carried away by the baseless alarms raised by the inexperienced persons
or lay people. For a nation like India, where patients compliance is
poor, the amount of expected adverse effects is low. One should not be
carried away if a drug is banned in x or y country, specially, when
Cost-effectiveness is an important factor. In India where only 30
percent people have seen the modern medicines we can not afford to stay
in ivory towers.

Jawahar S Bapna, MD, Ph.D
-----------------------------------------------------------------
Professor, Health & Pharmaceutical Management
Indian Institute of Health Management Research
1, Prabhudayal Marg, Airport Road
Jaipur 302 011
Phone  (O) 2791431, (H) 2620828; Fax 2792138
email: jbapna@iihmr.org


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