2025年11月ACSoMP建议

The World Health Organization (WHO) Advisory Committee on Safety of MedicinalProducts (ACSoMP) held its 24thmeetingon24–25 November2025as a hybrideventwith Membersparticipatingbothin person in Geneva and virtually.Established in 2003,ACSoMP is an independent expert advisory body that provides advice to the Director- The November 2025 meetingreviewedprogress on previous ACSoMP recommendationsand addressedkey safety issuesrelated topriority productsthat may be consideredforinclusionor have already been includedin WHO clinical guidelines,theEssentialMedicines List andtheWHO prequalification programme. Discussionscovered Safety monitoring of moxidectin in mass drug administration Moxidectin is an oral macrocyclic lactone with potent microfilaricidal activity againstOnchocerca volvulus. Compared with ivermectin, single-dose moxidectin achievesdeeper and more sustained suppression of skin microfilariae, a key reservoir fortransmission of onchocerciasis.WHO has not yet issued programmaticrecommendations on moxidectin but evidence generation for guideline development Summary ofACSoMPconclusions andrecommendations: •The risk of serious events such as encephalopathy in recipients infected withLoaloa is well understoodon the basis ofexperience with ivermectin, warrantingadditional risk minimization measures to prevent suchadverse drug reactions(ADRs)in affected patients. Testing for Loaloa is important in regions wherethe •The Committeerecommends that countries enhance spontaneous reportingmechanisms or strengthen existingpharmacovigilance(PV)systems in regionstargeted for MDA activities,including bysupporting community health workers toreport and conduct investigations on serious adverse events. Integration of these •Data on efficacy and safety of moxidectin in pregnancyarelacking and,given thatpregnancy exposuresarehighly likely inMDAs, active follow-up of pregnancyexposures is important.The Committeerecommends establishing pregnancy •TheCommitteeemphasizes the need for targeted research on repeated annualdosing safety, pregnancy and lactation outcomes, drug–drug interactions with •The Committee looks forward to receiving updated data on safety in pregnancy and Paracetamol during pregnancy and potential association with autism in offspring TheCommittee reviewed WHO’s approach to evaluating current scientific evidence onthe use of paracetamol during pregnancy and its possible association withautismspectrum disorder (ASD)andattention deficit-hyperactivity disorder (ADHD). TheCommittee discussed therecent umbrella reviewthatassessedthe possibleassociation between paracetamol,pregnancy and ASD andADHD, recognizing the such asnonsteroidal anti-inflammatory drugsand opioids andthelimited data to ACSoMPreinforcedthe importance of developing a fit-for-purpose communicationstrategythat educates thepublic on statistical challenges such as confounding andbias, the evolving definition of outcomessuch asASD and the challenge of assessingthe safety of sporadic and often over-the-counter exposures as with paracetamol use. ACSoMPalsostressed theneed for leadership in developing guidelines on robust post-marketing surveillance studies in pregnancy and the importance of ensuring thatmethodologies are robust, taking into consideration clear definition of exposuresand Summary ofACSOMP recommendations: •TheCommittee supports WHO’s efforts to performaliving systematic review. ThePICO questions in the review should assess whether studies looked at timing ofexposure, dose, duration and frequency of treatment, the clinical/public health •TheCommittee noted that the studies claiming an association are of poor quality •TheCommitteehighlighted the need for clear and unambiguous communicationwiththe public, so that pregnant women are not unintentionally driven towardsother analgesics with known serious and potentially life-threatening risks for thefetus and neonate.•TheCommittee emphasized the need for robust post-marketing surveillance toassess the safety of medicines used in pregnant and breastfeeding women Teratogenic concerns of topiramate and updates on sodium valproate regional TheCommittee reviewed whether maternaluse of the antiseizure medicinetopiramatejustifies a unique ICD-11 classification forneurodevelopmental disorders following a recommendation made by ACSoMP in May 2024. Whiletopiramate is associated withaknownincreased risk of oral clefts in infants born tomothers exposedto the medicine, ACSoMP was also updated onregional initiativesrelated to safety issues with valproate SummaryofACSoMP recommendations: •The Committeedoes not recommend proceeding with ICD coding for topiramate-related neurodevelopmental disorders at this point, as evidence is insufficient andinconclusive. Studies show mixed results, lack specificity, and have major Adverse drug reactions causality assessment This session focused on updating the Committee on the development of a standardizedmethodology for causality assessmentof advers