EMA warning about Flupirtine-containing medicines for pain relief


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[1] 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.

The press release is available by clicking here.

For more information on the European regulatory system for medicines, please consult our brochure.

We would be grateful if you could disseminate this email to anyone else who might be interested in this document.

With kind regards,

Nathalie Macle
Stakeholders and Communication Division

European Medicines Agency
30 Churchill Place
London, E14 5EU
United Kingdom