PRAC recommends restricting the use of flupirtine-containing medicines

Committee also recommends weekly monitoring of patients’ liver function

19-Jun-2013 - United Kingdom

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The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of flupirtine-containing medicines and recommended restrictions in their use. The Committee recommended that oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults who cannot use other painkillers (such as NSAIDs and weak opioids) and that treatment should not exceed two weeks.

In addition, patients should have their liver function monitored after each full week of treatment and treatment should be stopped if there are signs of liver problems. The PRAC also recommended that flupirtine must not be used in patients with pre-existing liver disease or suffering from alcohol abuse as well as in patients taking other medicines that cause liver problems.

The PRAC’s recommendations follow concerns raised by the German medicines regulatory agency, the Federal Institute for Drugs and Medical Devices (BfArM), about reports of liver problems in patients taking flupirtine. The problems ranged from cases of high levels of liver enzymes in the blood to liver failure cases, some of which were fatal or resulted in liver transplantation. BfArm was also concerned about the lack of data on the use of the medicine in treating chronic (long-term) pain.

The PRAC agreed that while there were data from studies of flupirtine in treating acute pain, the data on long-term pain were less convincing. The Committee noted the lack of sufficient data on the benefits of flupirtine when used for longer than 4 weeks.

With regard to liver safety, the PRAC noted that the duration of treatment seemed to be relevant to the occurrence of liver problems and that no cases of liver failure or liver transplantation were reported for patients who took the medicine for 2 weeks or less.

Considering the data on the benefits in acute pain, as well as the data on the occurrence of liver problems, the PRAC concluded that the proposed restrictions and regular liver monitoring were required to ensure that the benefits of flupirtine outweigh their risks.

https://www.bionity.com/en/news/143624/prac-recommends-restricting-the-use-of-flupirtine-containing-medicines.html