E-DRUG: RFI: Nimesulide ADRs?
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Can anyone please educate me adequately on the adverse
reactions that necessitated the regulatory ban on
marketing of Nimesulide in India, as I feel somehow
uncomfortable about its status as the most preferred
NSAID in my hospital and my inability to access
sufficient unbiased scientific information on it ?
Thank you.
Olutayo A. Moronkeji
Drug Information Pharmacist-Designate
Wesley Guild Hospital
Ilesa,
NIGERIA.
oamoronkeji@yahoo.com
[dear Olutayo, this question has been raised before in E-drug. Please consult our archives at http://www.essentialdrugs.org/edrug/archives.php
There are 66 hits for nimesulide! WB]
E-DRUG: RFI: Nimesulide ADRs? (2)
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Dear Olutayo A. Moronkeji,
The drug has not been banned completely. However, the use of drug has been made under the close supervision of physician. The possible reason is the
hepatotoxicity observed in children after prolonged use.
regards,
Rakesh Chaurasia
Pharmacist, Regulatory Affairs
Macleods Pharmaceuticals Ltd,
Mumbai,
India
chaurasiarakesh@macleodspharma.com
E-DRUG: RFI: Nimesulide ADRs? (3)
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India does not have the required infrastructure to
effectively monitor adverse drug reactions (ADRs).
Therefore doctors and regulators have to depend upon
information from other countries and institutions such
as USFDA, MHRA, TGA etc. for approving or banning any
drug such as astemizole, terfenadine, phenformin,
rofecoxib etc.
Unfortunately Nimesulide is not approved for use in
major western countries such as USA, Britain, Canada,
Australia, Denmark etc. Therefore its ADRs can not be
monitored.
Following certain nimesulide-related deaths in
Portugal and Finland, the European Medicine Evaluation
Agency (EMEA)reviewed the safety aspects of Nimesulide
and banned its use in children below 12 years.
In adults, its use was restricted to just three
disorders: acute pain, osteoarthritis and
dysmenorrhoea. Its earlier use for fever is not
permitted in EU.
In India, the Drugs Controller General (DCGI)has not
taken any action following EMEA directive. Its use is
permitted right from Day 0 (i.e. neonate) up to adults
for a wide variety of disorders including fever.
Dr. Chandra M. Gulhati
Editor, MIMS INDIA
(Monthly Index of Medical Specialities)
e-mail: indianmims@yahoo.co.in
seeemgee@yahoo.co.uk
E-DRUG: RFI: Nimesulide ADRs? (4)
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dear E-druggers,
Nimesulide is already a prescription drug called
Schedule H in India; hence legally it can be bought
only against a doctor's prescription. However retail
chemists in India routinely sell prescription drugs
without prescriptions. The Drugs Controller General,
India (DCGI)has not directed that Nimesulide be used
"under the supervision of a doctor." It would be
superfluous to issue such direction.
Dr. Chandra M. Gulhati
Editor, MIMS INDIA
(Monthly Index of Medical Specialities)
indianmims@yahoo.co.in
seeemgee@yahoo.co.uk
E-DRUG: RFI: Nimesulide ADRs? (5)
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Dear All:
India again! Things which happen everywhere don't happen here even if it is
for a good cause. I ask Dr Gulati-- can't we over 1 billion people or to be
more precise a little over 0.5 million medical professionals in India do something about it or persuade DGCI to take action in the larger interest of the society.
Aren't examples of USA, Britain, Canada, Australia, Denmark (where it is nimesulide is banned) are sufficient for DGCI to take action. Or human lives here are different than in these countries. It is always said in defence that though it is banned there but since we don't have a system in place it is not so here and so on.
Can't DGCI take action on the basis of ADR's or drug related deaths in other
countries OR it has to wait for the similar deaths to first occur here
before some action will be taken. If that is not so than how come action on
rofecoxib was taken so quickly.
Regards,
Dr Anupam Aggarwal, MD
Managing Director, Clinicsindia
India
clinicsindia@vsnl.net
E-DRUG: RFI: Nimesulide ADRs? (6)
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Dear Dr Agarwal,
The medical profession also needs to own up their prescribing practices.
When the proof is overwhelming, why these drugs need to be prescibed, when
alternatives are available. Once the docotrs stop prescribing, the
pharmaceutical companies have no option but withdraw them.
Legislative measures alone will not be very effective.
Dr P.H. Rao M.Pharm., Fellow (IIMB)
Professor - Health Management,
Administrative Staff College of India,
Bella Vista,
HYDERABAD. 500082
Phone: 91-40-23310952; Extn: 279
Fax: 91-40-223312954
drphrao@asci.org.in
E-DRUG: RFI: Nimesulide ADRs? (7)
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Dear E-druggers,
In spite of hue and cry against nimesulide, its very unfortunate that DCGI
(India) has still not directed that nimesulide should be used under
supervision or with precaution.
There are lots of research paper on nimesulide induced ADRs reported in India. For reference, see only these papers/informations published from our department only:
1). Rahman SZ, Khan RA. Is nimesulide safe in a cardiovascular-Compromised
patient?.Indian J Pharmacol 2004;36:252-253
[http://www.ijp-online.com/article.asp?issn=0253-7613;year=2004;volume=36;is
sue=4;spage=252;epage=253;aulast=Rahman ]
2). R. A. Khan & S. Z. Rahman. Nimesulide Induced Coronary Artery
Insufficiency - A Case Report. J Pharmacovigilance Drug Safety 2004; 1:11-13
3). R. A. Khan & S. Z. Rahman. A Case Report on Nimesulide and Its Relation
with Angina. J Pharmacovigilance Drug Safety 2004; 1: 19-21
4). KC Singhal & SZ Rahman. Nimesulide Induced Hepatitis in a child of 5
years: A Case Report, Newsletter of Society of Pharmacovigilance, India
2003; 1: 6-7
5). CD ROM, Appropriate Use of Antipyretics / Analgesics in Children, Health
Informatics, New Delhi, 2004
Sincerely yours,
S. Ziaur Rahman
Dr. Syed Ziaur Rahman
Lecturer
Dept. of Pharmacology
Jawaharlal Nehru Medical College
AMU, Aligarh 202002
rahmansz@sancharnet.in
E-DRUG: RFI: Nimesulide ADRs? (8)
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Dear colleagues,
What I do not understand about this whole discussion is why nimesulide
should be available on any market? Originally the manufacturer claimed
that it was a COX-2 inhibitor. While this was manifestly untrue, even if it
had been the case, that is hardly an advantage after what happened with
Vioxx. As a NSAID it has no proven advantage over any other similar
drug, especially relatively safe off-patent OTC alternatives such as
ibuprofen and naproxen. So let's forget about this drug, it is not needed.
Best wishes,
Dr Leo Offerhaus
Netherlands
offerhausl@euronet.nl
E-DRUG: RFI: Nimesulide ADRs? (9)
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dear E-druggers,
Unfortunately many prescriptions in India (may be
elsewhere also) are "incentive-driven." (Reference:
BMJ, April 4, 2004). Nimesulide is a highly profitable
product: 1350% profits to be precise. So there is lot
of money to throw around.
While the Government of India has placed aspirin under
price control, there is no restriction on the price or
profitability of Nimesulide which has no business to
exist in the first place.
Dr. Chandra M. Gulhati
Editor, MIMS INDIA.
(Monthly Index of Medical Specialities)
seeemgee@yahoo.co.uk