Nimesulide must be withdrawn worldwide due to serious liver damage

Nimesulide must be withdrawn worldwide due to serious liver damage

Press release
December 2007
International Society of Drug Bulletin Logo Contact:
Christophe Kopp

Nimesulide must be withdrawn worldwide due to serious liver damage

Nimesulide exposes patients to fatal liver damage. When a non-steroidal anti-inflammatory drug is needed, it is better to use one with a favourable benefit-harm balance such as ibuprofen. EU authorities fail to protect consumers.

The International Society of Drug Bulletins (ISDB) deems it unacceptable that nimesulide has been allowed to remain on European and some other markets in the world. This non-steroidal anti-inflammatory drug (NSAID) offers no therapeutic advantage or better gastrointestinal safety compared with other NSAIDs, whereas it exposes patients to a higher risk of fatal hepatic disorders.

Nimesulide has never been approved for use in countries like USA, UK, Canada, Australia New Zealand, Japan and other countries in view of concerns over its safety profile.

In 2002, Finland and Spain withdrew nimesulide from the market following reports of serious liver damage. Cases including 2 deaths had also been reported in France at the time. Ireland and Singapore decided to withdraw nimesulide from the market in 2007.

The European Medicines Agency has confirmed the hepatic risks associated with nimesulide in 2007, but merely limited the duration of treatment, leaving patients exposed to an unjustifiable fatal risk. These half-hearted measures are all the more unacceptable since numerous other available NSAIDs are just as effective and less dangerous.

How did a majority of EU member states’ rapporteurs who re-assessed nimesulide conclude that the product should remain on the market? Why is there such inconsistency among EU member states?

The Committee for Medicinal Products for Human Use (CHMP) assessed the harm caused by nimesulide in total secrecy and it is quite unacceptable for the EU health authorities to decide to limit only the duration of use without presenting the rationale behind this decision.

EU Commission’ unwillingness to withdraw nimesulide leads to EU citizens being unjustifiably exposed to preventable harm.

Nimesulide must be banned in the European Union and the rest of the world.

The International Society of Drug Bulletins

International Society of Drug Bulletin Logo The ISDB is a worldwide network of bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry.
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The following members contributed to this press release:
AIS-Nicaragua (Nicaragua)
Andrew Herxheimer (ex ISDB President)
arznei-telegramm (Germany)
Bilten O lijekovima & Pharmaca (Croatia)
BODHI (India)
Boletin Farmacos (Argentina)
Bulletin d’Information du Médicament et de Pharmacovigilance (France)
Bulletins d’Informations de Pharmacologie (France)
Butlleti Groc (Spain)
Dialogo sui farmaci (Italy)
DIC Newsletter (India)
Drug Information Center of National University (Colombia)
Farmakon/Slovensko Farmacevtsko Društvo (Slovenia)
Farmakoterapeutické Informace (Czech Republic)
Geneesmiddelenbulletin (the Netherlands)
Gute Pillen Schlechte Pillen (Germany) Informazioni sui farmaci (Italy)
Kusuri-no-Check (Japan)
La Lettre du GRAS (Belgium)
La revue Prescrire (France)
MEDEX, DrugInfo (Moldova)
PHARMA Drug Bulletin (Israel)
Pharma-Brief (Germany)
Pharmaflash (Switzerland)
Pharmakon (Spain)
Pharma-kritik (Switzerland)
The Belgian Centre for Pharmacotherapeutic Information (BCFI) (Belgium)
The Informed Prescriber (Japan)
Worst Pills, Best Pills News/ (USA)
Healthy Skepticism Inc (Australia)
Información Farmacoterapéutica de la Comarca/Boletín INFAC (Spain)
  • Dr. N. K. Mahanta
    Posted at 05:29h, 09 July Reply

    Nimesulide alone or in combination is widely found in Indian medicine market. People and patient buy it on prescription or on their own. Nobody is seemed to concern about its toxicity. WHO and UNICEF may jointly make a tryst to withdraw it from Indian health care sector.

    • Outi Päivärinne
      Posted at 15:45h, 06 August Reply

      And in Nepal, too. Please do something to make them aware of these risks!

      • dshhy
        Posted at 08:23h, 23 October Reply

        yeah . i have given this medicine for minimal left hydrocele . what should i do ?

    • Zoe Berson
      Posted at 08:49h, 03 November Reply

      To be honest. Nimesulide is a life saver for some. Take me for example. Im allergic to most NSAIDs except nimesulide. So banning it from the Indian Market is extremely inconsiderate for those few. Yes i do understand its harmful side effects, but while you all pop a paracetamol or ibuprofen and your problems are solved, people like us are struggling as drug research continues. So an alternate solution or rather a better one would be to give a safer substitute and then ban it.

  • Cesar
    Posted at 11:53h, 04 October Reply

    I would love to see real data about the danger to health. As far as I understand, the effects are grave, but rare, that’s why EMA though the beneficts suplants the dangers.

    Would you need a liver transplant after using nimesulide once? Twice? Ten times? What are the chances?

    • Alejandro Melo
      Posted at 12:38h, 12 January Reply

      If you see the figure 2 in the link, are indicated comparatively the risk, ant SALT trial reviewing authors are concluding: “This case-population study of liver transplant in over 227 million inhabitants could not demonstrate clearly different severe liver toxicity between the mainstream NSAIDs, and the upper limits of the 95% CIs, which indicate the greatest risk that one could confidently exclude, were similar. These results reproduce and confirm the results of population studies of less severe hepatic reactions”

  • Sita Ram
    Posted at 06:48h, 01 November Reply

    It is available in indian market due to submitting of fabricated clinical resesrch data to the should be withdraw from indian market.

  • Dr Omar
    Posted at 13:09h, 15 November Reply

    It is often found in a few of the pharmacies in Pakistan as well. We should address the PMDC and pull this medication from Pakistani pharmacies nation wide in lieu of the adverse drug profile.

  • Paulette Chin
    Posted at 06:58h, 28 November Reply

    I am shocked. I was given this drug on the 21.11.16 for 5 days to aid relieve the pain with Hemorrhoid attack . I was just checking it out because i realize the pain i was feeling is gone and i wasn’t told it was a pain killer. How could a hospital give this to me knowing its dangers….why would they do this? I’m gonna make a call right now!

  • Dr moeen Ahmed
    Posted at 21:31h, 12 March Reply

    I am pharmacist at Bhagat pura new shad Bagh Lahore the medicine ( nimsulied)salt are available all over the Lahore it dangerous to human Liver so it so it bans allover Pakistan people’s must be aware abut

  • Alexey
    Posted at 09:24h, 12 June Reply

    Yeah, sure! Ibuprofen us more safe? Really? Now US wants to ban Ibuprofen because it is super dangerous :))))) I think it is just about money and protecting the local markets.

    • Alvaro Seguro
      Posted at 07:34h, 15 November Reply

      Exactly, we have regressed as far as pain control is concerned imho, all these drugs (Paracetamol, Ibuprofen aspirin even) are much more insidious than the odd narcotic which as we know possesses little to no risks: of course there is the addictive properties coming into play but, yet, not long ago, laudanum was easily prescribed (so was diamorphine) by your GP and ´addiction` is not necessarily something associated with palliative care. A fact which should be obvious to all those who have faced/fought addiction – latter being triggered by misuse of a substance as opposed to a sporadic medicinal. Having said this, my very sporadic use of the substance (Nimesulide) unables me to tell the difference between it and its ´market competitors/bullies`. Sad, when we put our main organs at risk cause of a toothache or a back/joint ache when all a Doc/GP would have to do was to prescribe a few DFs (Codeine) or the odd Vicodin or something along those lines with ZERO risk to one´s health . Meh! Same old… same old… like there´s a conspiracy for us not to feel true relief and instead poison ourselves with the latest Big Pharma bloody product!!!!

    • Deda
      Posted at 07:59h, 16 August Reply

      I found this medicine when we lived in Ukraine. I brought a bunch home because it worked so well. I’ve never had any liver problems. But I have had stomach problems from Morton. I take only one package of the Nimesulide every couple of days verses taking 2400 mg of Ibuprofen a day, plus taking Tylenol too. And the Ibuprofen doesn’t even compare to the pain relief and anti inflammatory effects of the Nimesulide. To me the benefits outway the risks. I doesn’t use it all the time, just occasionally. I just think it’s a scam because the product eliminates the needs to take so much medicine. And it works really well. I’m more worried about ulcer and stomach bleeding from all the Ibuprofen…..

  • Valrie Shippey
    Posted at 14:04h, 15 September Reply

    Why would a doctor prescribed this tablet knowing that it is dangerous and can damage your liver?

  • Fox Lonestar
    Posted at 21:22h, 08 November Reply

    A nepali employee of mine is taking this drug. Almost every other month, she is having severe vomitting and abdominal pain. The doctor she sees is an indian doctor here in Texas – I’m not sure if he’s getting the drug for her to take. It wasn’t until tonight that I found the pills in her tool box and that Iooked up the side effects. One of her co-workers has been taking this for migraines, and has passed it around to others to take. Reading what this drug was prescribed for and the side effects, and now looking at my employees and how they get sick a lot, I’m beginning to see some major connections to this. Thank you very much for this information. This needs to be stopped now!

  • Dipak Nath
    Posted at 00:38h, 12 November Reply

    I have been taking this for a few years but not frequently and got no adverse reaction though I got rid of my synus pain.

  • Rogério Maciel
    Posted at 08:35h, 29 November Reply

    My opinion is contrary to what has been said here.I use Aulin 100 mg for more than 30 years with no problems whatsoever.
    I just can’t understand where is the danger…i believe that the competitors are afraid of Aulin, has it have give me no problems at all, even for my stomach.
    Of course, it should be taken with discipline and only when absolutely necessary, but that’s a rule to all the drugs.

    • karen cangelosi
      Posted at 18:12h, 06 December Reply

      As a relatively healthy person – no cardiac issues or liver issues but suffer from severe chronic pain, I rely on drugs like the banned drug Vioxx and Aulin. I never abused these drugs, only taking them when needed. Obviously, Vioxx should never have been prescribed to those with heart conditions and Aulin should not be taken by those with liver issues or with alcohol. All drugs can kill if taken incorrectly. Aulin is the only drug that relieves my pain. I fear if I could not get this drug, I would end up taking some type of opiate to get relief.

      • Deborah Byrne
        Posted at 07:25h, 12 January Reply

        Hi All ive just found this site and am only too aware of the dangers of Aulin. My mother was 3days away from her 58 th burthday when she became very unwell in 1996. She had taken Simon in late 1995 as she has siaticia. When the pain went she discontinued use. But the pain returned in early 96 and it was prescribed again.
        In her birthday she was jaundiced and the GP sent her for blood tests ( he suspected hepatitis) so it has to be sent abroad and would take several weeks. My mother was told she would be very sick but would be fine.
        She had TO take time off work and unuassly actually stayed in bed as she felt very unwell. 10 days after her symptoms started we decided as a family to ring an ambulance as she has really deteriorated. We found out later she was in full liver failure at that stage. She was moved to the liver unit, put at the top of the transplant list in Europe and recieved a liver transplant in the third day. Sadly she passed away the following day.
        DO NOT TAKE THIS MEDICATION . The cause of my mother’s death was not revieled to us, we discovered what happened when two other fatal cases ( one of who was a local women ) were holding inquests at the same time and an audit was started.
        Inemesulide was taken off the market here in 2007, they didn’t want to take it off. We as a family and the families of other people who died and others living with life limiting illness helped make a programme on primetime an RTE programme called bitter polls.
        We had our mother’s death Cert changed in 2017 to reflect the fact that nemesulide killed her not multi organ failure.
        RIP Mam
        Wishing you all good health.

    • Arjumand H
      Posted at 18:18h, 21 May Reply

      I use it when I have muscle pain or flu like symptoms, and find it an amazing/magical drug, especially for the latter . One can be so sick with the flu, but if you take this drug combined with tylenol only 2 times a day, you are ready to go to work! I like it because it is so gentle on my stomach, whereas other NSAIDS cause me severe acidity, its small dosage (very effective at 100mg dose vs 400 mg of Ibuprofen), fast acting and longer lasting action. The hepatotoxicity side effects might be true, but which NSAID does not carry that risk. Tylenol is one of the commonest over the counter drug causing liver damage. It should not be used long term for conditions like arthritis, but to ban it completely does not make sense. It is a powerful smooth muscle relaxant as well , and has applications in obstetrics as well for delaying labour, but due to the blanket ban, its benefits are not being utilised, which far outnumber the risks.

      • Alan Cassels @ TI
        Posted at 16:01h, 23 July Reply

        I am not sure that Tylenol (acetaminophen) has been banned. Part of the problem is that acetaminophen is in many over the counter cold and cough remedies and people can be consuming unsafe amounts of it without knowing. Thank you for your feedback.
        cheers, Alan Cassels, Communications director

  • Lewis Talley
    Posted at 21:36h, 08 January Reply

    The ISDB’s statement above that it “is a worldwide network of bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry” explains it all! Your local physician and hospital are most likely extremely “financially and intellectually” DEPENDENT on the pharmaceutical industry …… to give them returns on their investments! For that reason, of course, none of the products of their pharmaceutical partners are unsafe in this manner and are, therefore, their drugs of choice.

  • gayathri gaensan
    Posted at 08:51h, 23 April Reply

    As someone said, these medicines should also be banned in countries like India. It easily available and why is no one taking any action! I would be ready to do whatever it takes to get this banned in India.

  • Georgette
    Posted at 07:04h, 25 March Reply

    I have taken Messulid for years. I take it for menstrual cramps as well as acute pain in my feet and hands. It is the only drug that works for me. It works better than any another anti inflammatory that I have ever taken and it does not hurt my stomach. It should not be discontinued. I think you should be watched by a doctor when you take it but this drug is amazing and nothing works better for me.

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