Antipsychotics are increasingly prescribed for various disorders including bipolar disorder, schizophrenia, other psychotic disorders and to a lesser extent for depression, anxiety, insomnia and even nausea during pregnancy. The full knowledge about its possible effects due to exposure during pregnancy is still limited, although some studies refer to some degree of relationship with the appearance of effects such as gestational diabetes, premature birth, congenital malformations, our review did not find a sufficiently clear relationship with them. In addition to the safety profile, another aspect to consider is the assessment that untreated psychiatric disorders could also represent a risk factor for poor pregnancy outcomes. Therefore, due to the lack of highly significant data on these aspects during pregnancy, more studies are needed to provide more detail on the risks and benefits of these drugs at this stage. Los antipsicóticos son medicamentos cada vez más prescritos para diversos trastornos entre los cuales principalmente se encuentran el trastorno bipolar, la esquizofrenia, otros trastornos psicóticos y en menor medida para la depresión, ansiedad, insomnio e incluso náuseas durante la gestación. El conocimiento pleno sobre sus posibles efectos debido a la exposición durante la gestación resulta ser aún limitado, si bien algunos estudios refieren cierto grado de relación con la aparición con efectos como diabetes gestacional, parto prematuro, malformaciones congénitas, nuestra revisión no encontró una relación suficientemente clara con ellos. Además del perfil de seguridad otro aspecto a considerar es la valoración de que los trastornos psiquiátricos que no reciben tratamiento también podrían representar un factor de riesgo para malos resultados en la gestación. Por tanto, debido a la falta de datos con elevada significancia sobre estos aspectos durante el embarazo se requieren más estudios capaces de proporcionar mayor detalle de los riesgos y beneficios de estos fármacos en esta etapa.

Background/Objectives: The efficacy and safety profiles of CYD-TDV and TAK-003 are established, but multiple publications may derive from the same randomized trial population and therefore not represent independent evidence. We evaluated efficacy, immunogenicity, and safety while distinguishing independent trials from overlapping follow-up reports and interpreting absolute effects within each programme. Methods: We conducted a PRISMA 2020 systematic review and meta-analysis of randomized trials and follow-up reports from five databases. Outcomes included virologically confirmed dengue, hospitalization, severe dengue, serotype-specific efficacy, immunogenicity, and safety. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated; immunogenicity and safety were synthesized narratively. RoB 2 and GRADE were applied. Results: Nine reports were included. CYD-TDV reduced virologically confirmed dengue (RR = 0.41; 95% CI: 0.35–0.48) and hospitalization (RR = 0.41; 95% CI: 0.25–0.67). Across two independent CYD-TDV trials, absolute reductions were 23.2 virologically confirmed dengue cases per 1000 participants (NNV = 44) and 12.0–50.0 hospitalizations per 1000 (NNVs = 84–20). In the primary TIDES report, TAK-003 reduced virologically confirmed dengue (RR = 0.28; 95% CI: 0.22–0.35) and hospitalization (RR = 0.10; 95% CI: 0.05–0.18), with absolute reductions of 23.6 and 12.9 per 1000 (NNVs = 43 and 78). Later TIDES reports extended follow-up of the same population. Conclusions: Both vaccines reduced dengue outcomes within their respective trial programmes. Absolute effects should be interpreted according to baseline risk and trial context, not as direct between-vaccine comparisons. The synthesis distinguishes extended follow-up from independent replication.