Nimesulide

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The European Medicines Agency has completed a review of the safety and effectiveness of systemic medicines containing nimesulide (capsules, tablets, suppositories and powder or granules for oral suspension). The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of nimesulide used systemically continue to outweigh its risks but that its use should be restricted to the treatment of acute pain and primary dysmenorrhoea. It issued a recommendation that it should no longer be used for the treatment of painful osteoarthritis.

What is nimesulide?

Nimesulide is a non-selective non-steroidal anti-inflammatory drug (NSAID). It is used to treat:

  • acute (short-term) pain,
  • painful osteoarthritis (swelling in the joints) ,
  • primary dysmenorrhoea (period pains).

Medicines containing nimesulide have been available since 1985 and are authorised in a number of Member States. They are only available with a prescription. 

Systemic nimesulide medicines are available in the following Member States: Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia. Nimesulide-containing medicines are authorised but not marketed in Austria and in Ireland.

Why was nimesulide reviewed?

Nimesulide was reviewed in 2007 because of concerns with liver injury. The review procedure was triggered by the decision of Ireland’s medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, due to new information regarding cases of fulminant hepatic failure requiring liver transplantation. The Committee concluded that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum. To this effect the Committee recommended that treatment duration should be limited to a maximum of 15 days (packs were also limited to a two-week supply), that nimesulide should be restricted to second line treatment, and that doctors should be clearly informed of the risk. The CHMP also concluded that a fuller review of nimesulide was needed, that would look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original review.

Consequently, on 19 January 2010, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of nimesulide and to issue an opinion on whether the marketing authorisations for systemic medicine containing nimesulide should be maintained, varied, suspended or withdrawn across the European Union.

Which data has the CHMP reviewed?

The Committee reviewed available post marketing data from spontaneous reports of side effects, individual study reports and epidemiological (population-based) studies. It also reviewed data from the published literature, including published clinical studies, reviews and overviews and combined analyses of results from various studies (pooled analyses and meta-analyses).

What are the conclusions of the CHMP?

The Committee noted that the studies looking into the effectiveness of nimesulide in acute pain relief have shown that it is as effective as other NSAID pain killers such as diclofenac, ibuprofen and naproxen.

In terms of safety, the Committee noted that nimesulide has the same risk of causing stomach and gut problems as other NSAIDs. To limit the risk of side effects affecting the liver, several restrictions have already been introduced in the past, including restriction to second line treatment, the use of lowest effective doses for the shortest possible duration, and a maximum duration of treatment for acute pain.

The CHMP concluded that nimesulide was associated with an increased risk of liver toxicity compared with other anti-inflammatory treatments. The CHMP is now recommending, as a further restriction, that systemic nimesulide should no longer be used for treating painful osteoarthritis. The Committee considered that the use of systemic nimesulide for the treatment of painful osteoarthritis, which is a chronic condition, will increase the risk of the medicines being used for long-term treatment with a consequent increase in the risk of liver injury.

What are the recommendations for patients and prescribers?
  • Prescribers should no longer prescribe systemic nimesulide for treating painful osteoarthritis
  • Prescribers should review treatment of patients being treated for painful osteoarthritis with a view to choosing an appropriate alternative treatment.
  • Nimesulide should only be used as a second choice, and only in the treatment of acute pain or dysmenorrhoea.
  • Patient currently receiving systemic nimesulide for painful osteoarthritis should consult their doctor in order to arrange alternative treatment.
  • Patients who have any questions should speak to their doctor or pharmacist. 

The European Commission issued a decision on 20 January 2012.

Name Language First published Last updated
Questions and answers on the review of systemic medicines containing nimesulide BG = bălgarski 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide ES = español 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide CS = čeština 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide DA = dansk 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide DE = Deutsch 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide ET = eesti keel 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide EL = elliniká 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide EN = English 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide FR = français 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide IT = italiano 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide LV = latviešu valoda 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide LT = lietuvių kalba 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide HU = magyar 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide MT = Malti 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide NL = Nederlands 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide PL = polski 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide PT = português 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide RO = română 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide SK = slovenčina 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide SL = slovenščina 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide FI = suomi 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide SV = svenska 23/06/2011 19/04/2012

Key facts

Approved nameNimesulide
International non-proprietary name (INN) or common name

nimesulide

Associated names
Class
Reference numberEMEA/H/A-31/001261
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusEuropean Commission final decision
Opinion date23/06/2011

All documents

Name Language First published Last updated
Nimesulide - Article 31 referral - Assessment report (English only) 19/04/2012  
Nimesulide - Article 31 referral - Annex I BG = bălgarski 19/04/2012  
Nimesulide - Article 31 referral - Annex I ES = español 19/04/2012  
Nimesulide - Article 31 referral - Annex I CS = čeština 19/04/2012  
Nimesulide - Article 31 referral - Annex I DA = dansk 19/04/2012  
Nimesulide - Article 31 referral - Annex I DE = Deutsch 19/04/2012  
Nimesulide - Article 31 referral - Annex I ET = eesti keel 19/04/2012  
Nimesulide - Article 31 referral - Annex I EL = elliniká 19/04/2012  
Nimesulide - Article 31 referral - Annex I EN = English 19/04/2012  
Nimesulide - Article 31 referral - Annex I FR = français 19/04/2012  
Nimesulide - Article 31 referral - Annex I IT = italiano 19/04/2012  
Nimesulide - Article 31 referral - Annex I LV = latviešu valoda 19/04/2012  
Nimesulide - Article 31 referral - Annex I LT = lietuvių kalba 19/04/2012  
Nimesulide - Article 31 referral - Annex I HU = magyar 19/04/2012  
Nimesulide - Article 31 referral - Annex I MT = Malti 19/04/2012  
Nimesulide - Article 31 referral - Annex I NL = Nederlands 19/04/2012  
Nimesulide - Article 31 referral - Annex I PL = polski 19/04/2012  
Nimesulide - Article 31 referral - Annex I PT = português 19/04/2012  
Nimesulide - Article 31 referral - Annex I RO = română 19/04/2012  
Nimesulide - Article 31 referral - Annex I SK = slovenčina 19/04/2012  
Nimesulide - Article 31 referral - Annex I SL = slovenščina 19/04/2012  
Nimesulide - Article 31 referral - Annex I FI = suomi 19/04/2012  
Nimesulide - Article 31 referral - Annex I SV = svenska 19/04/2012  
Nimesulide - Article 31 referral - Annex II BG = bălgarski 19/04/2012  
Nimesulide - Article 31 referral - Annex II ES = español 19/04/2012  
Nimesulide - Article 31 referral - Annex II CS = čeština 19/04/2012  
Nimesulide - Article 31 referral - Annex II DA = dansk 19/04/2012  
Nimesulide - Article 31 referral - Annex II DE = Deutsch 19/04/2012  
Nimesulide - Article 31 referral - Annex II ET = eesti keel 19/04/2012  
Nimesulide - Article 31 referral - Annex II EL = elliniká 19/04/2012  
Nimesulide - Article 31 referral - Annex II EN = English 19/04/2012  
Nimesulide - Article 31 referral - Annex II FR = français 19/04/2012  
Nimesulide - Article 31 referral - Annex II IT = italiano 19/04/2012  
Nimesulide - Article 31 referral - Annex II LV = latviešu valoda 19/04/2012  
Nimesulide - Article 31 referral - Annex II LT = lietuvių kalba 19/04/2012  
Nimesulide - Article 31 referral - Annex II HU = magyar 19/04/2012  
Nimesulide - Article 31 referral - Annex II MT = Malti 19/04/2012  
Nimesulide - Article 31 referral - Annex II NL = Nederlands 19/04/2012  
Nimesulide - Article 31 referral - Annex II PL = polski 19/04/2012  
Nimesulide - Article 31 referral - Annex II PT = português 19/04/2012  
Nimesulide - Article 31 referral - Annex II RO = română 19/04/2012  
Nimesulide - Article 31 referral - Annex II SK = slovenčina 19/04/2012  
Nimesulide - Article 31 referral - Annex II SL = slovenščina 19/04/2012  
Nimesulide - Article 31 referral - Annex II FI = suomi 19/04/2012  
Nimesulide - Article 31 referral - Annex II SV = svenska 19/04/2012  
Nimesulide - Article 31 referral - Annex III BG = bălgarski 19/04/2012  
Nimesulide - Article 31 referral - Annex III ES = español 19/04/2012  
Nimesulide - Article 31 referral - Annex III CS = čeština 19/04/2012  
Nimesulide - Article 31 referral - Annex III DA = dansk 19/04/2012  
Nimesulide - Article 31 referral - Annex III DE = Deutsch 19/04/2012  
Nimesulide - Article 31 referral - Annex III ET = eesti keel 19/04/2012  
Nimesulide - Article 31 referral - Annex III EL = elliniká 19/04/2012  
Nimesulide - Article 31 referral - Annex III EN = English 19/04/2012  
Nimesulide - Article 31 referral - Annex III FR = français 19/04/2012  
Nimesulide - Article 31 referral - Annex III IT = italiano 19/04/2012  
Nimesulide - Article 31 referral - Annex III LV = latviešu valoda 19/04/2012  
Nimesulide - Article 31 referral - Annex III LT = lietuvių kalba 19/04/2012  
Nimesulide - Article 31 referral - Annex III HU = magyar 19/04/2012  
Nimesulide - Article 31 referral - Annex III MT = Malti 19/04/2012  
Nimesulide - Article 31 referral - Annex III NL = Nederlands 19/04/2012  
Nimesulide - Article 31 referral - Annex III PL = polski 19/04/2012  
Nimesulide - Article 31 referral - Annex III PT = português 19/04/2012  
Nimesulide - Article 31 referral - Annex III RO = română 19/04/2012  
Nimesulide - Article 31 referral - Annex III SK = slovenčina 19/04/2012  
Nimesulide - Article 31 referral - Annex III SL = slovenščina 19/04/2012  
Nimesulide - Article 31 referral - Annex III FI = suomi 19/04/2012  
Nimesulide - Article 31 referral - Annex III SV = svenska 19/04/2012  
Nimesulide - Article 31 referral - Annex IV BG = bălgarski 19/04/2012  
Nimesulide - Article 31 referral - Annex IV ES = español 19/04/2012  
Nimesulide - Article 31 referral - Annex IV CS = čeština 19/04/2012  
Nimesulide - Article 31 referral - Annex IV DA = dansk 19/04/2012  
Nimesulide - Article 31 referral - Annex IV DE = Deutsch 19/04/2012  
Nimesulide - Article 31 referral - Annex IV ET = eesti keel 19/04/2012  
Nimesulide - Article 31 referral - Annex IV EL = elliniká 19/04/2012  
Nimesulide - Article 31 referral - Annex IV EN = English 19/04/2012  
Nimesulide - Article 31 referral - Annex IV FR = français 19/04/2012  
Nimesulide - Article 31 referral - Annex IV IT = italiano 19/04/2012  
Nimesulide - Article 31 referral - Annex IV LV = latviešu valoda 19/04/2012  
Nimesulide - Article 31 referral - Annex IV LT = lietuvių kalba 19/04/2012  
Nimesulide - Article 31 referral - Annex IV HU = magyar 19/04/2012  
Nimesulide - Article 31 referral - Annex IV MT = Malti 19/04/2012  
Nimesulide - Article 31 referral - Annex IV NL = Nederlands 19/04/2012  
Nimesulide - Article 31 referral - Annex IV PL = polski 19/04/2012  
Nimesulide - Article 31 referral - Annex IV PT = português 19/04/2012  
Nimesulide - Article 31 referral - Annex IV RO = română 19/04/2012  
Nimesulide - Article 31 referral - Annex IV SK = slovenčina 19/04/2012  
Nimesulide - Article 31 referral - Annex IV SL = slovenščina 19/04/2012  
Nimesulide - Article 31 referral - Annex IV FI = suomi 19/04/2012  
Nimesulide - Article 31 referral - Annex IV SV = svenska 19/04/2012  
Questions and answers on the review of systemic medicines containing nimesulide BG = bălgarski 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide ES = español 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide CS = čeština 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide DA = dansk 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide DE = Deutsch 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide ET = eesti keel 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide EL = elliniká 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide EN = English 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide FR = français 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide IT = italiano 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide LV = latviešu valoda 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide LT = lietuvių kalba 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide HU = magyar 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide MT = Malti 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide NL = Nederlands 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide PL = polski 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide PT = português 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide RO = română 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide SK = slovenčina 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide SL = slovenščina 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide FI = suomi 23/06/2011 19/04/2012
Questions and answers on the review of systemic medicines containing nimesulide SV = svenska 23/06/2011 19/04/2012

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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