Flupirtine-containing medicinal products

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Review of flupirtine-containing medicines started

Medicines still being used outside current restrictions and cases of liver damage have continued to be reported

The European Medicines Agency (EMA) has started a new review of the benefits and risks of flupirtine-containing medicines for pain relief.

The review was requested by the German medicines authority, the Federal Institute for Drugs and Medical Devices (BfArM), and follows a previous EMA review in 2013 which introduced measures to restrict the use of these medicines because of reports of serious liver problems associated with their use.

As part of the measures from the earlier review, flupirtine use was limited to no more than 2 weeks in patients who could not use other pain treatments and tests of liver function were introduced before and during treatment. EMA also requested studies to show whether these restrictions were effective in reducing the risks. Results from some studies have now become available and suggest that, although the number of treated patients has gone down, the medicine is still being used outside the restrictions introduced in 2013. Furthermore, cases of serious liver damage associated with this medicine have continued to be reported.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has therefore begun a further review to determine how the latest available data affects the balance of benefits and risks for these medicines and to decide whether additional regulatory action should be taken. While the review is ongoing, patients who have any concerns about their medication should speak to their doctor or pharmacist.

More about the medicine

Flupirtine is an analgesic (a medicine for pain relief) used to treat acute (short-lived) pain for up to 2 weeks, in patients who cannot use other pain medicines such as opioids or nonsteroidal anti-inflammatory medicines (NSAIDs). Flupirtine works as a ‘selective neuronal potassium channel opener’. This means that it opens specific pores on the surface of nerve cells called potassium channels. The opening of these channels reduces the excessive electrical activity that leads to many pain states.

Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Austria, Estonia, Germany, Latvia, Lithuania, Luxembourg, Poland, Portugal, and Slovakia. They are available under several trade names and in different formulations.

More about the procedure

The review of flupirtine has been initiated at the request of Germany, under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. As flupirtine-containing medicines are all authorised nationally, the PRAC recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.

Key facts

About this medicine

Approved nameFlupirtine-containing medicinal products
International non-proprietary name (INN) or common name


Associated names-

About this procedure

Current statusUnder evaluation
Reference numberEMEA/H/A-31/1458
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.

Decision making modelPRAC-CMDh
Authorisation modelNationally authorised product(s)

Key dates and outcomes

Procedure start date26/10/2017

All documents

Procedure started

Name Language First published Last updated
Flupirtine Article-31 referral - PRAC list of questions null 2017-10-27  
Flupirtine Article-31 referral - Annex I null 2017-10-27 2017-12-04
Flupirtine Article-31 referral - Timetable for the procedure null 2017-10-27  
Flupirtine Article-31 referral - Review started null 2017-10-27  
Flupirtine Article-31 referral - Notification null 2017-10-27  

Document description:

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

Current status:
Under evaluation