The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed EMA’s recommendation to withdraw the marketing authorisation for the pain medicine flupirtine, because of the risk of serious liver injury. This means that the medicine will no longer be available.
The EMA recommendation was the outcome of a review of flupirtine medicines which was started because liver problems continued to be reported even after measures were introduced in 2013 to manage this risk. These measures had included limiting flupirtine use to no more than 2 weeks in patients with acute pain who could not use other painkillers, and carrying out weekly tests of liver function during treatment.
The review, carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice. It also assessed cases of serious liver damage reported since the 2013 review.
The CMDh agreed with the PRAC conclusion that the restrictions introduced in 2013 have not been sufficiently followed, and cases of serious liver injury, including liver failure, still occurred. In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.
The CMDh therefore agreed that patients taking flupirtine-containing medicines continue to be exposed to serious risks which outweigh the benefits of these medicines. In order to protect public health, the CMDh endorsed the PRAC recommendation to withdraw the marketing authorisations of flupirtine-containing medicines.
The CMDh examines questions relating to the marketing authorisation of human medicines in two or more European Union (EU) Member States in accordance with the mutual recognition or the decentralised procedure, and questions concerning variations of these marketing authorisations.