2025-06-26-世界卫生组织-2025_May_ACSoMP_recommendations_3页_82kb

Summary of ACSoMP 21st Meeting Key Recommendations and Conclusions

The 21st meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) addressed safety concerns for semaglutide, updates on sodium valproate usage, and the standardization of adverse drug reaction (ADR) reporting through WHO core variables.

Semaglutide and Potential Risk of NAION

Semaglutide, a GLP-1 receptor agonist, was reviewed for its potential link to nonarteritic anterior ischemic optic neuropathy (NAION), a serious cause of sudden vision loss in type 2 diabetes patients. A large Danish study suggested a higher incidence of NAION among semaglutide users, but supporting evidence was inconsistent, and other studies showed no significant link. The committee concluded the evidence is inconclusive due to methodological limitations. Recommendations include:

• Coordinating further investigation with regulatory authorities.
• Updating the risk management plan to include NAION and additional pharmacovigilance activities.
  Post-meeting notes confirm NAION as a "very rare" side effect (affecting up to 1 in 10,000 patients) and advise discontinuing semaglutide if vision loss occurs.

Sodium Valproate Usage: Persistent Risks and Recommendations

Despite its affordability and efficacy, sodium valproate (an anti-seizure medication) continues to be widely used, particularly in low- and middle-income countries (LMICs), due to persistent teratogenic and neurodevelopmental risks in women and girls of childbearing potential. A study by IQVIA showed valproate's prevalence in LMICs, while data on risk minimization measures (RMMs) is limited and inconsistently measured across countries. The committee emphasized the need for:

• Better data sources, especially from LMICs, to inform targeted risk strategies.
• A WHO repository for adaptable RMMs, supported by regional offices.
• Monitoring neurodevelopmental ADRs via VigiBase, focusing on LMICs.
• Endorsement of a Moroccan pilot study to evaluate RMM effectiveness and prescriber behavior.

Implementation of WHO Core Variables for ADR Reporting

The meeting discussed progress in implementing WHO's 35 core variables for suspected ADR reporting, introduced in November 2023 to standardize pharmacovigilance data. Comparative analysis in the WHO South-East Asia region highlighted variable implementation levels. The Uppsala Monitoring Centre emphasized the integration of these variables into the VigiMobile platform, which improves offline usability and data quality. Bhutan is set to fully implement VigiMobile by January 2027. The committee recommended electronic tools to support standardized reporting and urged countries to enhance data convergence and accuracy.