THE FALL of THE NIMESULIDE: from
the Stairways of HEAVEN !!! LA CAIDA DEL NIMESULIDE:
de las Escaleras del Cielo !!!
Data-Medicos
Dermagic/Express No. 5-(120)
30 Septiembre 2.003 / 30 September 2.003
EDITORIAL ESPANOL
=================
La reciente evaluaciķn de nimesulide por la Agencia europea para la Evaluaciķn
de
Productos Medicinales (EMEA) DE la molecula NIMESULIDE para su uso en pacientes
que padecen una variedad ancha de condiciones inflamatorias y dolorosas, luego
de una
LARGA EVALUACION de 16 meses acerca del beneficio de la molécula y el perfil de
riesgo da como conclusion FINAL despues que las noticias malas empezaron a
llegar sobre
efectos adversos de la MOLECULA. El EMEA ha prohibido su uso simultáneamente en
los niņos debajo de 12 aņos de edad. AGENCIA EUROPEA PARA LA EVALUACION
DE PRODUCTOS MEDICINALES.
Dermagic Express se anota TREMENDO TRIUNFO despues de una larga batalla que
inicio en al aņo 2.001 DENUNCIANDO LOS EFECTOS ADVERSOS de esta molecula
y su toxicidad hepatica, tanto en niņos como adultos. Esta noticia PUBLICADA EN
INTERNET EL DIA 28 DE AGOSTO DEL 2.003 es una FECHA
HISTORICA para el DERMAGIC EXPRESS y los niņos del mundo que nunca jamas recibiran los efectos
nocivos de esta medicina
Muchos decian que esta molecula ERA UNA DE LAS MARAVILLAS del siglo,
pero nunca fue aprobado en PAISES DESARROLLADOS como Estados Unidos, Canada, UK,
Australia, Nueva Zelanda, y paises escandinavos, Pequeņos paises como Portugal,
Israel, Sri-Lanka y Bangladesh se quejaron y clamaron por el retiro de la droga.
En el aņo 2.002 fue retirado de Espaņa y Finlandia por el innovador Boehringer.
La union Europea recientemente habia advertido sobre las serias complicaciones
del uso de esta droga. LA
EMEA, AGENCIA EUROPEA PARA LA EVALUACION DE PRODUCTOS
MEDICINALES. tambien sugiere a los medicos restringir
EL USO DE NIMESULIDE
EN ADOLESCENTES.
En VENEZUELA sigue vendiendose, esperemos que las autoridades sanitarias del
pais
tomen conciencia y saquen del mercado de una buena vez esta medicina por sus
alto riesgo
en niņos, como ya el DERMAGIC LO HABIA PUBLICADO EN OTRAS OCASIONES.
LA CAIDA DEL NIMESULIDE ES una realidad total, solo es cuestion de tiempo para que
sea prohibida en adultos tambien.
DERMAGIC EXPRESS PIONERO EN ESTA LUCHA contra el NIMESULIDE,
comercializado en venezuela bajo los NOMBRES DE AULIN, AINEX, SCAFLAN,
NORMOSILEN, y otros, quiere agradecer a todas las AUTORIDADES DE EUROPA quienes
tomaron conciencia sobre esta MOLECULA y ejecutaron esta HISTORICA RESOLUCION.
NO LE MEDIQUES NIMESULIDE A TU HIJO MENOR DE 12 AŅOS !!!! ni a
ADOLESCENTES.
Saludos a todos
Dr. Jose Lapenta R
EDITORIAL ENGLISH
================= The recent nimesulide
evaluation for the European Agency for the Evaluation of
Medicinal products (EMEA) OF the molecule NIMESULIDE for their use in patient
that they suffer a wide variety of inflammatory and painful conditions,
following a 16-month-long evaluation of the molecule’s benefit/ risk profile
gives as FINAL conclusion after the bad NEWS began to arrive on adverse effects
of the MOLECULE. The EMEA has prohibited its use
simultaneously in the children under 12 years of age. EUROPEAN AGENCY
FOR THE EVALUATION DE MEDICINAL PRODUCTS.
Dermagic Express one scores TREMENDOUS VICTORY after a long battle that
beginning in a year 2.001 DENOUNCING THE ADVERSE EFFECTS of this molecule
and their hepatic toxicity, in children and adult. This PUBLISHED news IN
INTERNET THE DAY AUGUST 28 of year 2.003 are a
HISTORICAL DATE for the one DERMAGIC EXPRESS, and the children of the world that will never receive the
noxious effects of this medicin.
Many said that this molecule was ONE of THE MARVELS of the century, but never been licensed for use in developed economies
like US, Canada, UK, Australia, New Zealand and Scandinavian countries. Small
countries like Portugal, Israel and our neighbours Sri- Lanka and Bangladesh
have shown the guts and grit to withdraw the drug. Nimesulide was withdrawn in
2002 by the innovator, Boehringer from Spain and Finland. The European Union has
recently issued a precautionary advice on the marketing of this drug
following serious complications after its use.
THE EMEA, EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS. he also suggests the doctors to restrict THE
USE OF NIMESULIDE
IN ADOLESCENTS.
In VENEZUELA it continues being sold, let us wait that the sanitary authorities
of the country
take conscience and take out of the market this medicine for
their high risk
in children. the DERMAGIC it has already PUBLISHED IT IN OTHER OCCASIONS.
THE FALL OF THE NIMESULIDE is a total reality , it is question of time so
that
be also prohibited in adults.
DERMAGIC EXPRESS PIONEER OF THIS FIGHT against the NIMESULIDE,
marketed in venezuela under the brand NAMES: AULIN, AINEX, SCAFLAN,
NORMOSILEN, and other, wants to thank to all the AUTHORITIES of EUROPE that
they took conscience in this MOLECULE and they make this HISTORICAL RESULUTION
Don't PRESCRIBE NIMESULIDE TO YOUR SON
below of 12 YEARS!!!! neither to
ADOLESCENTS.
Greetings to all
Dr. José Lapenta R
=========================================================
BIBLIOGRAPHICAL REFERENCES /
REFERENCIAS BIBLIOGRAFICAS
=========================================================
1.) NPIL to replace nimesulide with `Vah'
2.) PIL seeks ban on manufacture, sale of Nimesulide
3.) Nimesulide again / banned its use in children below 12 years of age.
4.) EMEA (European Agency for the Evaluation of
Medicinal Products) ban: Nimesulide market slips further
5.) NIMESULIDE
6.) NIMESULIDE: THE CURRENT CONTROVERSY
7.) Nimesulide: farmaco sotto osservazione.
8.) Nimesulide Induced Hepatitis in a child of 5 years: A Case Report
9.) NIMESULIDE ED EPATOTOSSICITA'
=========================================================
THE
NIMESULIDE ADVERSE EFFECTS
(HOT LINK I )!!!
THE
NIMESULIDE SHOULD BE RETIRED FROM THE WORLD MARKET
(HOT LINK II
)!!!
THE
NIMESULIDE SECRET X-FILE
(HOT LINK III)
!!!
=========================================================
1.) NPIL to replace nimesulide with `Vah'
=========================================================
Source:
http://www.thehindubusinessline.com/ P.T.
Jyothi Datta
NEW DELHI, Jan. 20 2001
EVEN as the debate goes back and forth on the use of nimesulide, a popular fever
drug, Nicholas Piramal India Ltd has decided to phase out its version of the
drug, Orthobid and replace it with Vah (Valdecoxib), touted to be a "better drug
with less side-effects".
Nimesulide, a non-steroid anti-inflammatory analgesic, had been put under a
scanner by the Drug Controller General of India (DCGI) following concerns raised
by the medical community on the safety of the drug, particularly when
administered to children.
Following the note of caution, sounded by regulatory authorities in other
countries, a section of the medical community in India too voiced its concern on
paediatric use leading to liver toxicity. That the DCGI is reported to have
cleared the use of the drug in adults and paediatric use is something that the
medical fraternity is not willing to endorse.
Other companies that have nimesulide in their product portfolio include Panacea
Biotec, with its popular Nimulid and Dr Reddy's Nise, among others.
However, the controversy around the drug had nothing to do with NPIL's decision
to replace its brand of Nimesulide with a more efficacious drug, NPIL top-brass
told Business Line.
"We are constantly on the look out for better drugs that have less side-effects
and the launch of Vah, about two months ago is part of that exercise."
Orthobid, an estimated Rs 6 crore brand, was never recommended for paediatric
use, the official further pointed out.
And if the existing confusion was not worrying enough, earlier this month, a
forum called the Indian Academy of Paediatrics wrote to the DCGI stating that
nimesulide was "as safe or unsafe as other anti-pyretic drugs".
===============================================================
2:) PIL seeks ban on manufacture, sale of Nimesulide
===============================================================
Source: http://www.hindu.com/
By Our Staff Reporter
CHENNAI SEPT. 26. A public interest litigation petition seeking to ban the
manufacture and sale of Nimesulide, a non-steroidal and anti-inflammatory drug,
has been filed in the Madras High Court.
The First Bench comprising the Chief Justice, B. Subhashan Reddy, and Justice A.
Kulasekaran, admitted the petition filed by the Tamil Nadu Health Development
Forum, and ordered notices to the Union Health Secretary and the Drugs
Controller-General of India.
The forum secretary and the former Director of the Institute of Child Health at
the Government Children's Hospital here, C.S. Rex Sargunam, contended that
though it was not an anti-fever drug it can bring down the temperature faster
than other anti-fever drugs like paracetamol.
He said the drug could cause severe sideeffects. ``A person does not die of
fever and joint pain, but dies of liver or kidney damage caused by the repeated
use of Nimesulide''.
According to Dr. Sargunam it was the most expensive non-steroided anti-inflammatory
drug and was not under the price control regime of the respondent-authorities.
In developed countries such as the United States, Britain, Canada and Australia,
Nimesulide is not approved for use even for adults, whereas Finland, Spain,
Turkey, etc., have banned the drug, the petition claimed.
Dr. Sargunam prayed for a direction to ban the manufacture and marketing of
Nimesulide.
=============================================================
3.) Nimesulide again / banned its use in children below 12 years of age.
=============================================================
Source:
http://www.expresspharmapulse.com/ 28th
august 2003
THE recent evaluation of nimesulide by the European Agency for the Evaluation of
Medicinal Products as safe and effective for use in patients suffering from a
wide variety of inflammatory and painful conditions, following a 16-month-long
evaluation of the molecule’s benefit/ risk profile must have come as much needed
relief for its Swiss developer and licensor Helsinn Healthcare SA and Indian
manufacturers who have been facing a downslide in market shares after bad news
started spilling out. The EMEA has simultaneously banned its use in children
below 12 years of age. The drug is available in India since 1995 and is among
the largest prescribed NSAIDs in India and is one of the leading OTC products,
too. According to a press release, 3 crore bottles of suspension have been sold
in India since the introduction of the molecule. The release says about 18-20
lakh children are “getting relieved” from fever every month if the suspension
sales data is converted into usage. Not a bad drug promotion idea, though.
The release, interestingly, does not talk about the ban on its administration to
neonates, infants and children. It is interesting to note that paediatricians
have a weakness for nimesulide suspensions after they diagnose children as
suffering from fever which needs immediate management. The product has been so
pushed by the manufacturers that doctors tend to prescribe three days of
paediatric doses of the medicine which is supposed to be used only for two doses
and be replaced by other medication if the fever shows no signs of subsiding.
Doctors cannot be faulted for this as parents, in their anxiety to see the child
back to normalcy, prod him to show quick results. So where the simple
paracetamol could manage, doctors hand out a nimesulide prescription. Studies
have talked about the harmful effects of nimesulide on the liver, but the Indian
government has chosen not to act and place a fast-acting medicine on the black
list. There are a few doctors who say that nimesulide should not be misused in
children, but the majority feels otherwise. Indian doctors have used nimesulide
more for its anti-pyretic properties than anti-inflammatory, whereas it is very
well known that it is hepatotoxic. Blue Cross withdrew its paediatric
suspensions of nimesulide from the market in the wake of the controversy, but
others have not been so charitable. An Indian company, which developed a once-daily
dosage form of nimesulide over an year back, is finding no international takers.
This amply shows that global players no more factor nimesulide in their
businesses. It is worrisome if the Indian government has chosen to ignore the
controversy just because a section of the industry has embarked on an exercise
to ensure that the highly profitable business continues without any hitch. It
may not matter to the regulators as to how bad the chemical in the tablet is as
long as the kid who pops it is not theirs. This is probably the attitude of the
government and the bureaucracy.
=============================================================
4.) EMEA ban: Nimesulide market slips further
=============================================================
Source:
http://www.expresspharmapulse.com/
Jayashree Padmini - New Delhi 28 th August 2.003
Nimesulide manufacturers must be writhing in pain. The recent ban by The
European Agency for Evaluation of Medicinal Products on use of nimesulide in
children below 12 years of age has set the stage for another round of decline in
its sales.
Add to that the EMEA restriction on the use of the NSAID with analgesic and anti-pyretic
properties in adults, and you have the picture of a molecule needing a shot in
the arm.
The Nimes-ulide market is already degrowing. It had a growth rate of seven per
cent in October 2002 and is now degrowing at minus 10 per cent. Faster negative
growth rates are predicted in the coming months, according to experts.
Previously a growing molecule, Nimesulide has been witnessing a downtrend in
sales over the past few months owing to the vast media outcry in the country.
Nimesulide, which proved its vulnerability to national opinion, will have to now
face the repercussions of international angst apart from the domestic fall in
sales.
In comparison to October 2002, the sale of Nise paediatric tablets (Dr Reddy’s)
went down by 52.4 per cent and Nimulid paediatric tablets (Panacea Biotech)
declined by 44 per cent.
The paediatric suspensions of these two brands witnessed a decline of 22 per
cent and 29 per cent respectively.
It is not that the bad news has spared the adult dosages which are also feeling
the heat Nise 100mg tablet witnessed a 26.3 per cent decline whereas Nimulid
sales went down by 17 per cent.
The October 2002 moving annual turnover figure, according to retail market
research firm AC Nielsen-ORG-MARG, for Nimesulide was at Rs 200 crore. It
declined by 20 per cent by March 2003. Compared to March 2003, Nimesulide sales
went down by around 17 per cent in June 2003. The market research firm’s MAT
figure for March 2003 puts the Nimesulide sales at Rs 160 crore and, for June
2003, the figure is Rs 133 crore. Apart from the influence of media campaign
against Nimesulide, the decline was attributed to the DCGI’s ban on Nimesulide
drops and the discontinuation of Nimesulide combination products in the market
by Dr Reddy’s.
DRL’s decision to withdraw Nimesulide combination drugs was influenced by the
ongoing litigation in the Delhi High Court and the international market
sensitivities, points out MIMS Editor Dr Chandra M Gulhati.
An opinion mobilisation in the US market against Indian companies selling drugs
unauthorised by the DCGI could have detrimental impact on the market prospects
of these companies, he said.
The PIL fled by Social Jurist, urging Delhi High Court to ban Nimesulide,
particularly its use in children, was scheduled for hearing on August 27.
The issue of FDCs of Nimesulide will also be a focal point of the litigation
since the DCGI has admitted that they were being manufactured under licences
granted by state drug controllers without any marketing approval by the DCGI’s
office.
The ban by EMEA on children below 12 could very well
mean that physicians would restrain themselves from prescribing the drug to
adolescents as well.
Further, the international agency restricts the use in adults to a few
indications such as acute pain associated with osteoarthritis and dysmennorhoea
only. Use in fever and pain, and inflammation associated with dental diseases is
prohibited. Its topical form is to be used only for relief of pain due to
sprains and acute inflammation of tendons due to injury (traumatic tendonitis).
EMEA announced its decision early this month after a 16-month long review of the
controversial drug by experts drawn from European Union member states. The
reference to EMEA for its adjudication was made by the National Agency on
Medicines of Finland in April 2002. Earlier, countries like Finland, Spain and
Portugal had suspended the use of Nimesulide in the wake of reports of its
serious adverse effects on liver. In the Europe it was only Italy that has been
allowing use of Nimesulide in children, but above the age of six years.
=============================================================
5.) NIMESULIDE
=============================================================
Source:
http://www.saluteoffresi.it/News/Nimesulide.htm
L'Auroritā Sanitaria finlandese ha sospeso in via cautelativa la
Nimesulide (Nimed) per effetti indesiderati a livello epatico.
Al Servizio di Farmacovigilanza finlandese sono giunte nel corso di pochi anni
di commercializzazione del prodotto 109 segnalazioni di reazioni avverse, di cui
66 di tossicitā epatica.
Nella maggioranza dei casi si tratta solamente di innalzamento dei livelli degli
enzimi epatici. In alcuni casi si sono avute epatiti, tra cui una morte sospetta.
La Nimesulide č un antinfiammatorio molto usato e ben tollerato sotto l'aspetto
gastrico per la sua maggiore selettivitā per la ciclossigenasi-2. Č nota la sua
epatotossicitā, ritenuta maggiore rispetto agli altri FANS.
In Finlandia l'impiego della Nimesulide avviene anche per periodi molto
prolungati, aumentando in tal modo il rischio di reazioni avverse anche gravi.
Fonte: Nam 2002
=============================================================
6.) NIMESULIDE: THE CURRENT CONTROVERSY
=============================================================
CORRESPONDENCE
Source:
www.ijp-online.com/ Indian Journal of
Pharmacology 2003; 35: 121-122
Nimesulide, a non-steroidal anti-inflammatory
drug(NSAID) with anti-inflammatory, analgesic andantipyretic effects, was first
launched in Italy in 1985.Since then it has been aggressively marketed in about
50 countries throughout the world and still
commands a fair share of the NSAID market in the countries, where it continues
to be sold.
Though nimesulide is a preferential COX-2 inhibitor and therefore, assumed to be
safer in clinical use, its gastrointestinal tolerance has not been proven to be
superior to other NSAIDs because "variousepidemiological studies give little
weight to the hypothesis that selective inhibition of COX-2 may have a sparing
effect on the GI Tract"1. Some postmarketing surveillance studies confirmed the
tolerability profile of nimesulide 2 . Companies
marketing this drug like M/s Wander Limited in its product literature even
claimed that it was "devoid of common side effect of gastrointestinal ulceration
encountered with the use of NSAIDs". The hype generated about efficacy and
tolerability of nimesulide
ensured that its sales picked up, leaving the other NSAIDs behind. Dr Reddy's
Laboratories' brand became popular to take the leading position in OTC
sales.
Why the current controversy ?
Nimesulide was aggressively promoted in India and attained the top position
as anti-pyretic in private practice. But recently the status of nimesulide
became questionable following reports of fatal adverse drug reactions (ADR). The
National Pharmacovigilance Centre (CNF, Portugal) from 1993 to 99, received 17
ADR reports of nimesulide, which included skin (five), hepatic (four),
peripheral edema (two), stomatitis (two), paraesthesia (one), thrombo-
cytopenic purpura (one), irritability (one) and headache/reduced visual acuity
in (one). The ADRs relating to skin were rash in three, urticaria/ angioedema in
one and necrotising fasciitis in one, which evolved to septicemia and death.
From the hepatic ADRs, two which occurred in children were compatible with Reye’s
syndrome and both resulted
in fatality. Also seen was one case of cholestasis and another of liver enzyme
elevation and coagulopathy, the later being fatal 3 . Another report informed
three
cases of fixed drug eruptions with nimesulide 4. Nimesulide induced liver injury
gained investigative interest and was found to present with hepatocellular
necrosis or cholestasis. Many cases of nimesulide induced hepatotoxicity have
been reported 5 , some of which have been fatal 6 . Patients with liver toxicity
had the hallmark of hypersensitivity with an increase
in blood and tissue eosinophilia. From clinical and histological data, it
appears that both immunological and metabolic idiosyncratic reactions can be
involved as the pathogenetic mechanism of nimesulide induced liver disease. Even
if the risk of hepatotoxicity
is small and fatality rare, nimesulide use for fever particularly in children
cannot be justified when a safer alternative like paracetamol is available.
Neonatal renal failure following the use of nimesulide has been reported 7
Not many of the doctors are aware of the fact that
due to its toxicity, ADRs and suspected danger, nimesulide has
never been licensed for use in developed economies
like US, Canada, UK, Australia, New Zealand and Scandinavian countries. Small
countries like Portugal, Israel and our neighbours Sri- Lanka and Bangladesh
have shown the guts and grit to withdraw the drug. Nimesulide was withdrawn in
2002 by the innovator, Boehringer from Spain and Finland. The European Union has
recently issued a precautionary advice on the marketing of this drug
following serious complications after its use.
Medical activists highlighted the rampant misuse and overuse of nimesulide, and
its ADRs leading to fatalities in children through various media, including
cable TV. Letters appeared in press warning the nimesulide users of its toxicity
8. It is a matter of great concern that while other countries banned the sale
of this drug, the Drug Controller-General of India (DCGI) merely ordered a
review of this drug. The DCGI has gone on record to admit that due to powerful
commercial interests, it might be difficult to get objective answers even from
doctors. True to the anticipated fears, Delhi Medical Association has declared
nimesulide safe 9 ! Criticising this act of DMA,
leading paediatricians and neonatologists of Indiaį have questioned the validity
of this survey from 50 doctors of Delhi who gave clean chit to nimesulide.
CORRESPONDENCE
Editor of Monthly Index of Medical Specialities(MIMS) has rightly pointed that
ADR monitoring is not done by any professional body of doctors in the world 10
Industrial interests surely prevail over professional ethics and obligations.
Following the recent communication from the DCGI to various industry, consumer
and professional bodies to be part of the review committee for nimesulide, it
has been reported in the news that Dr. Reddy’s Laboratories whose branded
nimesulide reportedly accounts for about 40-45 percent share of Rs 190
crore domestic market, is believed to have withdrawn its paediatric preparation
of nimesulide from the market 11. If this is really true, we appreciate the
concern of this company and hope others will follow suit. Most of the drug
research is funded by the pharmaceutical industry. However let not the ADR
monitoring be dictated by the manufacturers of drug,
suspected to cause ADR. If this does not happen, the truthful reporting will
never occur because of the vested interest of the powerful industry lobby. More
disturbing is the influence, when organized gang of 50 private practitioners
opines in favour of the dangerous drug and their opinion is considered to let
the drug thrive in largest democracy, against the
global rejection. While the leading countries of the world have not allowed /
banned or withdrawn the drug, the opinion of a mere fifty private doctors has
tilted the scale towards allowing the drug to continue to be marketed in India!
It is also a matter of great sorrow that matters relating to serious and fatal
ADRs of drugs are discussed in the media first and not in scientific bodies.
Because we continue to miserably fail in taking a stand, the
media continues to lead and beat us. No wonder that 50 organized private
practitioners have succeeded in brain washing those who finally matter. At least
they had the courage to say, even if wrong.
V. THAWANI, S. SONTAKKE, K. GHARPURE, S. PIMPALKHUTE
Department of Pharmacology, Government Medical College, Nagpur-440 003.
e-mail: [email protected]
REFERENCES
1.Jouzeau JY, Terlain B, Abid A, Nedelec E, Netter P. Cyclo-oxygenase isoenzymes
: how recent findings affect thinking about nonsteroidal antiinflammatory drugs.
Drugs 1997;53:
563-82.
2. Pochobradsky MG, Mele G, Beretta A. Postmarketing survey of nimesulide in the
short term treatment of osteoarthritis. Drugs Exper Clin Res 1991;17:197-204.
3. World Health Organisation. Nimesulide Adverse Reactions reported to the CNF.
WHO ADR Newsletter 1999;2:6.
4. Cordeiro MR, Goncalo M, Fernandes B. Nimesulide : Fixed drug eruption: 3 case
reports. Contact Dermatitis 2000; 43:307.
5. Dourakis SP, Sevastianos VA, Petraki K, Hadziyannis SJ. Nimesulide-induced
acute icteric hepatitis. Society for Medical Studies 2001;79:3.
6. Schattner A, Sokolovskaya N, Cohen J. Fatal hepatitis and renal failure
during treatment with nimesulide. J Int Med 2000;247:153-5.
7. Balasubramaniam J. Nimesulide and neonatal renal failure. Lancet
2000;355:575.
8. Thawani V. Nimesulide, a dangerous drug. The Hitavada (Nagpur) 2002 Oct 15; p
8.
9. Jain K. Controversial drug may get government consent. Times of India (Mumbai)
2002 Dec 17; p 7.
10. Jain K. Doctors question IMA survey on nimesulide. Times of India (Mumbai)
2003 Jan 14; p 1.
11. Rajwadkar K. Paediatric nimesulide withdrawn from market. Nagpur: The Indian
Express (Nagpur) 2003 Jan 2; p 13.
=============================================================
7.) Nimesulide: farmaco sotto osservazione.
=============================================================
DIPARTIMENTO ASSISTENZA FARMACEUTICA AZIENDA USL DI RE
Il Ministero sta valutando informazioni su Nimesulide
Source:
http://www.ausl.re.it/
--------------------------------------------------------------------------------
La Azienda Usl di Reggio Emilia comunica che nessun farmaco a base di nimesulide
č inserito nel Prontuario Terapeutico Locale in uso presso i propri Ospedali. Il
farmaco nimesulide č commercializzato come medicinale a denominazione generica :
Nimesulide o come specialitā medicinale con uno dei seguenti nomi di fantasia:
Algimesil, Algolider, Antalgo, Areuma, Aulin, Aulin Mite, Biosal,
Dimesul,Doloxtren, Domes, Edemax, Efridol, Eudolene, Fansidol, Flolid, Isodol,
Laidor, Ledolid, Ledoren, Mesulid, Mesulid mite, Mesulid Fast, Nerelid, Nide,
Nimedex, Nimenol, Nimesil, Nimesulene, Nimexan, Nims, Noalgos, Noxalide, Remov,
Resulin, Solving, Sulidamor, Sulide, Teonim.
--------------------------------------------------------------------------------
Comunicato N° 81 del 19 marzo 2002
Ministero della Salute
Ufficio Stampa
Il Ministero della Salute informa che le Autoritā sanitarie della Finlandia
hanno comunicato, a tutte le Agenzie europee, di aver predisposto un
provvedimento di sospensione della vendita delle specialitā medicinali
contenenti come principio attivo la nimesulide. Tale provvedimento si č basato
sulla osservazione di una alta frequenza di effetti avversi di tipo epatotossico
in pazienti che avevano assunto questo tipo di medicinali. Il Ministero della
Salute, in collaborazione con le altre Agenzie europee, sta valutando tutte le
informazioni disponibili. In Italia la nimesulide č largamente usata dal 1985 (nel
2000 e nel 2001 sono state prescritte circa 24 milioni di confezioni per anno).
Gli episodi segnalati in Italia riguardanti reazioni epatossiche sono stati a
tutt'oggi circa il 5% delle oltre 450 segnalazioni registrate nella banca dati
della Farmacovigilanza italiana. Tali effetti sono previsti e descritti nella
scheda tecnica italiana dei prodotti contenenti nimesulide e nel foglietto
illustrativo che accompagna queste confezioni. Inoltre nella sezione speciali
avvertenze e precauzioni per l'uso viene raccomandato: "I pazienti che durante
il trattamento con Nimesulide presentino alterazione dei tests della funzione
epatica e/o manifestino sintomi compatibili con un danno epatico (anoressia,
nausea, vomito, ittero) devono essere attentamente monitorizzati ed il
trattamento deve essere interrotto. Questi pazienti non dovranno essere pių
trattati con Nimesulide". La Nimesulide inoltre č controindicata nella
insufficienza epatica. Una pių alta frequenza di questo tipo di eventi in
Finlandia rispetto all'Italia potrebbe essersi verificata per via di una diversa
modalitā di uso di questi prodotti nei due Paesi. In Italia, infatti, la
nimesulide č utilizzata principalmente per brevi periodi per trattare il dolore
di lieve intensitā. Il Ministero della Salute ribadisce l'esigenza di utilizzare
tutti i medicinali solo nelle condizioni cliniche indicate in quanto nessun
farmaco č esente da possibili effetti collaterali. L'utilizzo dei farmaci al di
fuori delle indicazioni previste espone gli utilizzatori a dei rischi inutili.
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8.) Nimesulide Induced Hepatitis in a child of 5 years: A Case Report
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Source:
http://www.medbeats.com/ K. C. Singhal* &
S. Z. Rahman
Department of Pharmacology, J. N. Medical College, AMU, Aligarh-202002
*Honorary Consultant, WHO Collaborating Center for ADR Monitoring,
Uppsala,Sweden
Introduction:
Nimesulide (4-nitro—2 phenoxymethane sulphonamide), which is a nonsteroidal anti-inflammatory
drug, has been available in the Indian Market since 1997 for its antipyretic and
anti-inflammatory activity. None of the reports in medical literature indicate
its superior efficacy as antipyretic as compared to paracetamol and anti-inflammatory
compared with other drugs of this class such as diclofenac and piroxicam.
Numerous studies have established the life threatening adverse events with
nimesulide such as hepatotoxicity, renal toxicity, severe skin reactions
including fixed eruptions, gastrointestinal toxicity, potentiation of seizures,
potentiation of colitis in passive cigarette smoking. A plethora of scientific
data shows that nimesulide should not be used as the primary mode of treatment
as an antipyretic or analgesic, especially in children, for whom much better and
safer choices are available. No rationale exists for selecting nimesulide as the
first drug of choice for fever or pain. Nimesulide is not used in the United
States, Finland, Spain, Portugal and Israel. These countries have withdrawn the
pediatric nimesulide formulation. The drug was never licensed for use in Canada,
Britain and Australia.
The continuing use of nimesulide for Indian children is shocking. Published
studies from India indicate rampant abuse of nimesulide. At least 12 paediatric
preparations of nimesulide are available in India, which affirms the widespread
use of the drug in children (1). Barring few, no dependable post-marketing
surveillance for adverse drug reactions is undertaken in India. Moreover, unlike
in the West, Indian doctors are not under any real supervision and therefore do
not necessarily keep up with the rapidly changing information about adverse
effects. Patients receiving nimesulide should be closely monitored for evolving
hepatic failure. Indian patients may not follow necessary guidelines, for simple
economic reasons.
Case Report:
Although there might be several cases of NSAIDs induced hepatic damage in
Aligarh and elsewhere that are not being reported, but we could find one
definite case of Nimesulide induced hepatitis in Aligarh.
The 5-year-old male child, wt 22 Kg came to see a private paediatric consultant
with a complaint of fever for the last 8 days on 28.2.2003. The history of
present illness was elicited from patient’s attendant who says that his child
was apparently well before 8 days when he developed fever, which was unrecorded,
continuous and low grade initially and not, associated with chills and rigors.
The fever has increased in intensity for the last 8 days (It is very hot to
touch the patient now). The fever was not associated with vomiting, cough or
yellow discoloration of urine or clay colored stool. The patient was seen by
pediatricians and started prophylactic treatment for Paratyphoid as Ofloxacin (Syrup
Zenflox Forte) 1-1/4 spoonful twice daily for 10 days, Syrup Corcef 100 mg twice
daily and Nimesulide (Syrup Nimica 50) 1-1/4 spoonful (5 ml). On second day,
Enzymes (Syrup Gastrium) for 6 weeks and Multivitamins + Iron (Elixir Nigoadine)
1-1/4 spoonful thrice daily were added.
Haemogram and widal test were done. On the same day of visiting, the widal came
out to positive. Other examination showed pulse rate as 110 /min; respiratory
rate – 18/min; temperature 1040 F; pallor – mild; no icterus; tongue coated. On
systemic examination, chest bilaterally was clear, on per abdominal examination,
no tenderness, spleen was palpable but no hepatomegaly was there. No abnormality
was detected during CVS and CNS examination. Patient had no history of jaundice
in past or history of blood transfusion or antitubercular treatment or any other
drug as such. Family history showed no history of contact with jaundiced patient
in family. Immunization status showed no history of receiving Hepatitis B
Vaccines.
After 15 days of the above treatment i.e. on 15.3.2003, the patient felt
weakness and on 18.3.2003, the patient was diagnosed as a case of jaundice on
the basis of the following signs and symptoms. On general examination, icterus
was present, the liver found to be three-fingers enlarged and firm,
simultaneously the spleen was also palpable; other systems were normal on
examination. Following investigation were advised and their outcome: S.
Bilirubin - 8.70 mg/dl; SGOT/AST - 293 U/L; SGPT/ALT - 785 U/L and Alkaline
Phosphatase - 22 KAU; Australia Antigen [Hbs Ag] and Malaria Parasite [ELISA] -
negative. One week after dechallenge of the suspected drug nimesulide, LFT was
again advised: S. Bilirubin – 0.8 mg/dl; SGOT/AST – 45 U/L; SGPT/ALT – 40 U/L
and Alkaline Phosphatase - 16 KAU. Causal relationship could thus be made on the
basis of temporal sequence and positive dechallenge.
Conclusion: Nimesulide, similar to other nonsteroidal anti-inflammatory drugs (NSAIDs),
has been associated with rare and unpredictable but serious hepatic adverse
reactions (2). Many studies showed that nimesulide causes the most frequent
dermatological and hepatic side effects in nature, including fatal Reyes
syndrome (3). Concomitant therapy with other drugs (amoxicillin/clavulanic acid,
lysine salicylate) in many of these cases prohibits a definitive causal link of
the adverse reaction to nimesulide therapy. Authors believe when more safer
drugs as paracetamol are already available it is irrational to prescribe me-too
drugs of doubtful efficacy. It is high time that Drug Control Authorities in
India review their policy for granting permission to drugs and drug formulations.
India has more than 65000 formulations approved by Drug Controller of India,
which is highest for any country in the world.
Even if the Indian drug control agencies are reluctant to impose a total ban on
nimesulide, they should immediately forbid its use for treatment of fever or
pain. It will be unfortunate if the Indian government waits for another "committee"
report before stopping the use of nimesulide, even for the treatment of pain or
fever, and lets more innocent patients suffer needlessly. Remember, in September
2002, the Drugs Controller General of India, ordered a review of the drug in
view of concerns of hepatotoxicity and the review committee came with the
distrustful results.
References:
Kunal Saha, Use of nimesulide in Indian children must be stopped, BMJ 2003;
326:713
Conforti A, Leone R, Moretti U, Mozzo F, Velo G., Adverse drug reactions related
to the use of NSAIDs with a focus on nimesulide: results of spontaneous
reporting from a Northern Italian area. Drug Saf 2001; 24(14): 1081-90.
Anonymous, SCRIP World Pharmaceutical News. PJB Publications, Ltd., London; No
2431, April 23, 1999: 20
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9.) NIMESULIDE ED EPATOTOSSICITA'
=============================================================
Source: http://www.ospfe.it/
LA NIMESULIDE E’ UN FARMACO ANTIINFIAMMATORIO NON STEROIDEO (FANS)
CORRENTEMENTE IMPIEGATO IN PIU’ DI 60 PAESI NEL MONDO DEI QUALI 10 EUROPEI.
DAL 1985, ANNO DELLA SUA COMMERCIALIZZAZIONE, ALL’AGOSTO 2001, SONO STATI
SEGNALATI A LIVELLO INTERNAZIONALE 1.104 EVENTI AVVERSI, DI CUI 195 (18% DI TIPO
EPATOTOSSICO).
PROBLEMA RILEVATO: IL 18 MARZO 2002 LE AUTORITA’ SANITARIE FINLANDESI NE HANNO
SOSPESO LA COMMERCIALIZZAZIONE IN SEGUITO A 66 SEGNALAZIONI, REGISTRATE
NELL'ULTIMO QUADRIENNIO, DI DANNI EPATICI GRAVI, TRA I QUALI DUE TRAPIANTI ED UN
DECESSO. LA SPAGNA, IN ATTESA DELLA VALUTAZIONE DA PARTE DELL'EMEA E SULLA BASE
DEI DATI FINLANDESI, HA DISPOSTO LA SOSPENSIONE CAUTELATIVA DELLA
COMMERCIALIZZAZIONE DELLE SPECIALITA' MEDICINALI CONTENENTI NIMESULIDE.
SITUAZIONE IN ITALIA: ALLA LUCE DI QUESTI AVVENIMENTI, IL MINISTERO DELLA SALUTE
HA EFFETTUATO UNA RIANALISI DELL’IMPIEGO DI NIMESULIDE IN ITALIA E DELLE
SEGNALAZIONI DI REAZIONI AVVERSE.
LO STUDIO HA EVIDENZIATO CHE LA NIMESULIDE E' LARGAMENTE IMPIEGATA in italia ma
con un uso diverso rispetto alla Finlandia essendo prevalentemente utilizzata in
Italia per terapie di breve durata; IL NOSTRO PAESE E' TRA I MAGGIORI
UTILIZZATORI DI QUESTO FARMACO: SI POSSONO STIMARE IN ITALIA OLTRE 10 MILIONI DI
PERSONE CHE NE FANNO USO, DELLE QUALI OLTRE 5 MILIONI CON PRESCRIZIONI A CARICO
DEL SSN. IL CONSUMO ITALIANO DI QUESTO PRINCIPIO ATTIVO RAPPRESENTA IL 60% DEL
CONSUMO MONDIALE: NEL 2001 SONO STATE VENDUTE 25.573.224 CONFEZIONI (PARI A 18
DDD/1000 ABITANTI-DIE).
AL 31 MARZO 2002 SONO STATE SEGNALATE IN ITALIA 27 SOSPETTE REAZIONI DI TIPO
EPATOTOSSICO COSI’ SUDDIVISE: 16 CASI DI EPATITE (DI CUI 3 FATALI MA CON NESSO
DI CAUSALITĀ “DUBBIO”), 4 CASI DI EPATITE COLESTATICA, 4 CASI DI ITTERO
EPATOCELLULARE E 3 CASI DI DOCUMENTATO AUMENTO DEGLI ENZIMI EPATICI. GLI EFFETTI
AVVERSI EPATOTOSSICI SONO GIA' PREVISTI E DESCRITTI NELLA SCHEDA TECNICA NONCHE’
NEL FOGLIETTO ILLUSTRATIVO.
LE SEDICI (16) SEGNALAZIONI SE RAPPORTATE AI CONSUMI SONO BEN AL DI SOTTO DEL
VALORE CONSIDERATO “CRITICO” DALLA FDA PER QUELLO CHE RIGUARDA LA EPATOTOSSICITā
DA FARMACI (1 SU 50.000 ESPOSTI) PUR CONSIDERANDO LA GENERALE SITUAZIONE DI
SOTTOSEGNALAZIONE IN ITALIA.
PERTANTO, IN CONSIDERAZIONE DELL'ELEVATO LIVELLO DI UTILIZZO DEL FARMACO E DEL
NUMERO DI SEGNALAZIONI PERVENUTE, IL MINISTERO DELLA SALUTE RITIENE CHE LA
SITUAZIONE NEL NOSTRO PAESE NON RICHIEDA, AL MOMENTO, PARTICOLARI INTERVENTI
RESTRITTIVI. TUTTAVIA STA ATTENTAMENTE SEGUENDO LA RIVALUTAZIONE DEL PROFILO
RISCHIO/BENEFICIO DELLA NIMESULIDE ATTUALMENTE IN CORSO A LIVELLO INTERNAZIONALE.
MISURE ADOTTATE IN ITALIA: IL MINISTERO DELLA SALUTE COMUNICA, ATTRAVERSO IL SUO
SITO WEB (WWW.sanita.it/farmaci/note_informative), UNA NOTA INFORMATIVA IN CUI
RIBADISCE ALCUNE RACCOMANDAZIONI:
ˇ I PAZIENTI CHE DURANTE IL TRATTAMENTO CON NIMESULIDE PRESENTINO ALTERAZIONE
DEI TEST DELLA FUNZIONE EPATICA E/O MANIFESTINO SINTOMI COMPATIBILI CON UN DANNO
EPATICO (ANORESSIA, NAUSEA, VOMITO, ITTERO) DEVONO ESSERE ATTENTAMENTE
MONITORIZZATI ED IL TRATTAMENTO DEVE ESSERE INTERROTTO. QUESTI PAZIENTI NON
DEVONO PIU’ ESSERE TRATTATI CON NIMESULIDE.
ˇ LA NIMESULIDE PUO’ ESSERE ACQUISTATA IN FARMACIA SOLO SU PRESCRIZIONE MEDICA.
ˇ E’ IMPORTANTE COMUNICARE TUTTE LE SOSPETTE REAZIONI AVVERSE AL FARMACO AI
SERVIZI FARMACEUTICI DELLE PROPRIE AZIENDE USL ED AZIENDE OSPEDALIERE.
LE REAZIONI INDESIDERATE NELLA REGIONE EMILIA-ROMAGNA: NEL 2001 SONO STATE
RILEVATE 16 SEGNALAZIONI DI PRESUNTE ADR DA NIMESULIDE A CARICO CUTANEO E
GASTROINTESTINALE (DI CUI IL 33% GRAVI). NON SONO STATE REGISTRATE SEGNALAZIONI
RIGUARDANTI EVENTI AVVERSI A CARICO DEL FEGATO.
LE REAZIONI INDESIDERATE NELLA PROVINCIA DI FERRARA:
DAL 1991 AL GIUGNO 2002, SONO PERVENUTE AL COORDINAMENTO DI FARMACOVIGILANZA
INTERAZIENDALE 12 PRESUNTE REAZIONI INDESIDERATE ATTRIBUIBILI A NIMESULIDE, UNA
DELLE QUALI HA EVIDENZIATO PROBLEMI EPATICI .
SI TRASCRIVE, DI SEGUITO, QUANTO INDICATO DAI MEDICI NOTIFICATORI SUI MODULI DI
SEGNALAZIONE:
-EDEMA DI QUINCKE
-ORTICARIA (4 segnalazioni )
-ERITEMA ALLE BRACCIA E GONFIORE ALLE LABBRA
-ALLERGIA CUTANEA DIFFUSA
-ANAFILASSI SEGUITA DA SOSPETTA SINDROME DI STEWENS-JOHNSON
-INSUFFICIENZA CARDIACA ACUTA (in associazione con naproxene)
-ULCERA GASTRICA E DUODENITE EROSIVA, MELENA ED ANEMIZZAZIONE (in
automedicazione )
-ERITEMA AL VOLTO ED INGUINO-SCROTALE
-DOLORE IN EPIGASTRIO ED IN IPOCONDRIO DX, ELEVAZIONE DI GOT E GPT (giugno 2002)
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DATA-MEDICOS/DERMAGIC-EXPRESS No 5-(120) 30/09/2.003 DR. JOSE
LAPENTA R.
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