The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended taking the nonopioid analgesic flupirtine off the market in Europe, concluding that the benefits of this pain medicine do not outweigh the risks, particularly the risk for liver problems.
In 2013, as reported by Medscape Medical News, the EMA endorsed recommendations to restrict the use of flupirtine-containing oral medicines and suppositories because of reports of serious liver problems.
The restrictions called for these analgesic medications to be used only for treating acute pain in adults who cannot use other agents, such as nonsteroidal anti-inflammatory drugs and weak opioids, and treatment should not last longer than 2 weeks. Weekly tests of liver function were also advised, and the EMA asked for studies to assess whether these restrictions were followed in clinical practice and were effective in reducing the risk for liver problems.
On the basis of an updated review of all available data, the PRAC has concluded that the restrictions introduced in 2013 have not been sufficiently followed in clinical practice, and cases of serious liver injury still occurred, including liver failure.
The committee looked into the possibility of introducing additional measures but could not identify any that would increase adherence to the restrictions and adequately reduce the risk of liver problems.
They concluded, therefore, that patients taking flupirtine-containing medicines “continue to be exposed to serious risks which outweigh the benefits of these medicines” and that they “recommended the withdrawal of their marketing authorizations,” the EMA said in a statement released February 9.
The PRAC recommendation will be considered by the Co-ordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a final position.
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