Effirma (flupirtine) / Theriva Bio, Viatris - LARVOL DELTA

[Human Single Drug Exposures to Non-opioid Analgesics Reported to the Poisons Information Centre Erfurt from 2003 to 2012.] (PubMed) - "Conclusions: Because many NOA are over-the-counter drugs, it is difficult to obtain data on their use. PIC data could provide information on the NOA use in the population."

Journal • Biosimilar • Oncology • Pain

EMA to review safety of flupirtine-containing pain meds (Medscape) - "The European Medicines Agency (EMA) announced today that they have begun a review of flupirtine-containing medications...'The review was triggered by the German medicines agency, the Federal Institute for Drugs and Medical Devices (BfArM), following an increasing number of reports of liver problems associated with the use of flupirtine...'...The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), responsible for evaluation of safety issues for human medicines, and a set of recommendations will be made."

European regulatory • Pain

June meeting highlights from EMA Pharmacovigilance Risk Assessment Committee (The Pharma Letter) - "The PRAC 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 because of the risk of damage to the liver."

Regulatory • Pain