LA CAÍDA DEL NIMESULIDE:  de las Escaleras del Cielo !!!   

Data-Médicos 
Dermagic/Express No. 5-(120) 
30 Septiembre 2.003 / 30 September 2.003 
 

EDITORIAL ESPANOL
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La reciente evaluación de nimesulide por la Agencia europea para la Evaluación de Productos Medicinales (EMEA) DE la molécula NIMESULIDE para su uso en pacientes que padecen una variedad ancha de condiciones inflamatorias y dolorosas, luego de una LARGA EVALUACIÓN de 16 meses acerca del beneficio de la molécula y el perfil de riesgo da como conclusión FINAL después que las noticias malas empezaron a llegar sobre efectos adversos de la MOLÉCULA. El EMEA ha prohibido su uso simultáneamente en los niños debajo de 12 años de edad. AGENCIA EUROPEA PARA LA EVALUACIÓN  DE PRODUCTOS MEDICINALES.

Dermagic Express se anota TREMENDO TRIUNFO después de una larga batalla que inicio en al año 2.001 DENUNCIANDO LOS EFECTOS ADVERSOS de esta molécula y su toxicidad hepática, tanto en niños como adultos. Esta noticia PUBLICADA EN INTERNET EL DIA 28 DE AGOSTO DEL 2.003 es una FECHA HISTÓRICA para el DERMAGIC EXPRESS y los niños del mundo que nunca jamás recibirán los efectos nocivos de esta medicina

Muchos decían que esta molécula ERA UNA DE LAS MARAVILLAS del siglo, pero nunca fue aprobado en PAÍSES DESARROLLADOS como Estados Unidos, Canadá, UK, Australia, Nueva Zelanda, y países escandinavos, Pequeños países como Portugal, Israel, Sri-Lanka y Bangladesh se quejaron y clamaron por el retiro de la droga. En el año 2.002 fue retirado de España y Finlandia por el innovador Boehringer. La Unión Europea recientemente había advertido sobre las serias complicaciones del uso de esta droga.

 LA EMEA, AGENCIA EUROPEA PARA LA EVALUACIÓN DE PRODUCTOS MEDICINALES. tambien sugiere a los medicos restringir EL USO DE NIMESULIDE EN ADOLESCENTES.

En VENEZUELA sigue vendiéndose, esperemos que las autoridades sanitarias del país tomen conciencia y saquen del mercado de una buena vez esta medicina por sus alto riesgo
en niños, como ya el DERMAGIC LO HABÍA PUBLICADO EN OTRAS OCASIONES.

LA CAÍDA DEL NIMESULIDE ES una realidad total, solo es cuestión de tiempo para que sea prohibida en adultos también.

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 MOLÉCULA y ejecutaron esta HISTÓRICA RESOLUCIÓN.

NO LE MEDIQUES NIMESULIDE A TU HIJO MENOR DE 12 AÑOS !!!! ni a ADOLESCENTES.

Saludos a todos

Dr. José 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

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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'

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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) !!!

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1.) NPIL to replace nimesulide with `Vah'
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Source: https://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".

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2:) PIL seeks ban on manufacture, sale of Nimesulide
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Source: https://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.


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3.) Nimesulide again / banned its use in children below 12 years of age.
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Source: https://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.

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4.) EMEA ban: Nimesulide market slips further
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Source: https://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.


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5.) NIMESULIDE 
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Source: https://www.saluteoffresi.it/News/Nimesulide.htm

L'Aurorità 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 tossicità 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 è un antinfiammatorio molto usato e ben tollerato sotto l'aspetto gastrico per la sua maggiore selettività per la ciclossigenasi-2. È nota la sua epatotossicità, 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
 

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6.) NIMESULIDE: THE CURRENT CONTROVERSY
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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 Indiaç 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.
 

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7.) Nimesulide: farmaco sotto osservazione.
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DIPARTIMENTO ASSISTENZA FARMACEUTICA AZIENDA USL DI RE
Il Ministero sta valutando informazioni su Nimesulide
Source: https://www.ausl.re.it/

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La Azienda Usl di Reggio Emilia comunica che nessun farmaco a base di nimesulide è inserito nel Prontuario Terapeutico Locale in uso presso i propri Ospedali. Il farmaco nimesulide è commercializzato come medicinale a denominazione generica : Nimesulide o come specialità 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.

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Comunicato N° 81 del 19 marzo 2002

Ministero della Salute
Ufficio Stampa

Il Ministero della Salute informa che le Autorità sanitarie della Finlandia hanno comunicato, a tutte le Agenzie europee, di aver predisposto un provvedimento di sospensione della vendita delle specialità medicinali contenenti come principio attivo la nimesulide. Tale provvedimento si è 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 è 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 più trattati con Nimesulide". La Nimesulide inoltre è controindicata nella insufficienza epatica. Una più alta frequenza di questo tipo di eventi in Finlandia rispetto all'Italia potrebbe essersi verificata per via di una diversa modalità di uso di questi prodotti nei due Paesi. In Italia, infatti, la nimesulide è utilizzata principalmente per brevi periodi per trattare il dolore di lieve intensità. Il Ministero della Salute ribadisce l'esigenza di utilizzare tutti i medicinali solo nelle condizioni cliniche indicate in quanto nessun farmaco è 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: https://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'
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Source: https://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 CAUSALITÀ “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 EPATOTOSSICITà 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:

· 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.

· LA NIMESULIDE PUO’ ESSERE ACQUISTATA IN FARMACIA SOLO SU PRESCRIZIONE MEDICA.

· 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-MÉDICOS/DERMAGIC-EXPRESS No 5-(120)  30/09/2.003 DR. JOSÉ LAPENTA R. 
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