[india-drug] Response to Toxicity of nimesulide

[Pipasha Biswas <b_pipasha@yahoo.co.uk>]

Response to Toxicity of nimesulide
-----------------------------------

Dear ALL,
It was indeed nice to receive the email on the toxicity of nimesulide 
written by Dr Bapna highlighting the toxicity of nimesulide.  

It is really sad to note that Dr Bapna thinks that Mr Sanjay Kumar has 
unecessarily raised the alarm for nimesulide toxicity.  Does it then 
mean that medical journalists should not let the lay public know and
not educate them on drugs and their side effects and public should not
be  aware of the common drugs that they take?
Of course one has to weigh the risks and benefits of medicines.  No one

argues on that risk benefit analysis.  The question is regulators 
should know when it is a risk? which unfortunately to be quite frank
the Indian regulators do not and so are the doctors and pharmaceutical 
companies.  Nor are the Indian regulators interested to learn from
other countries.
Dr Bapna mentions that nimesulide was first marketed in Italy, but he 
has forgotten to write that nimesulide is no longer used in Italy and 
also that other European countries where it was used have also
withdrawn  nimesulide due to hepatotoxicity.  He has also forgotton to
mention that nimesulide was never marketed in USA, UK, Canada or
Australia because of the same problem the regulatory agencies of these
countries learnt from other countries mistake and did not market it,
even though Dr Bapna mentions that as per evidenced based scientific
literature nimesulide is the safest pain reliever.  I wonder then why
it is not there in the Cochrane database as the safest pain releiver.
Regarding the reports that Dr Bapna mentions of in the WHO database on 
nimesulide, most of the reports generated for nimesulide are from all 
over the world  and (I have had the opportunity to regularly see the
ADR reports of WHO and analyse it) mostly the data is incomplete and
most of these reports are unassessable due to incomplete and
insufficient information.  Yes, Dr Bapna is right that hepatic toxicity
of paracetamol in the USA resulted in 26, 000 hospitalisations and 450
deaths, but did anyone of the researchers investigate how many deaths
we have due to paracetamol in India?
Dr Bapna mentions the sales figures for nimesulide and goes on to say 
that the adverse effects can be considered negligible.  Well I wonder 
how many ADRs in the rural population is ever reported by doctors and 
whether the doctors themselves or the patients as a matter of fact have

the idea that the adverse events were due to nimesulide or some other 
disease and hence do not bother to report it or are totally ignorant of

any pharmacovigilance system in India.
Yes, Dr Bapna is 100% right that nimesulide has been wrongly promoted 
in combinations with other drugs and admits that doctors and
pharmacists do not have any idea of the constituents of the drugs in
each of the  brands.
Dr Bapna mentions that the compliance of people in India is low and 
hence the incidence of ADRs is also low.  I think this is wrong.  I
think people can develop an ADR even with one dose of the drug and also
I  understand by the email I received from Prof SK Gupta that the
incidence of ADRs in the Natioanl Pharmacovigilance centre annually is
between 15-20%.  Well if that is the incidence then that is not low
specially when you have an incidence of ADRs in other countries which
is between 6-10%.
Lastly Dr Bapna mentions that one should not get carried away by x and 
y drugs banned in other countries.  Well India can only say this if it 
has a sound ADR reporting system and  can get answers to these fatal 
events from there own databases.  I wonder then, why thalidomide is not

used in India in pregnant ladies with hyperemesis, as the thalidomide 
tragedy affected mostly babies from the Western world and had almost no

phocomelia cases in India, and why other drugs like troglitazone is not

used in India for diabetes mellitus even though there were no cases of 
hepatotoxic fatalities reported from India?  I think it is always 
better to learn from other peoples mistakes and not repeat it yourself.
 
That is the wiser decision!!
Therefore, there is no place for complacency especially when you deal 
with safety of medicines which people use it all the time and brush off

this important topic of ADR monitoring.  It has to be proactive, and 
all healthcare professionals should join in hands to develop and 
understand this system better.  Then only can we learn from past
mistakes and 
move forward.  And as for medical journalists reporting on ADRs or any 
other medical issues, I think they are doing a wonderful job by 
educating the public of India and for this they should be commended.


Pipasha Biswas



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