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Schizophrenia is a chronic and severe pathology that is characterized by the presence of delusions, hallucinations, negative symptoms, disorganization of thought and behavior. Although its prevalence in children under 13 years of age is very low, it increases substantially during the adolescence. When it develops before 18 years of age, it is called early-onset schizophrenia and represents 12-33 % of all individuals with this disorder. Drugs such as haloperidol, risperidone, paliperidone, aripiprazole, olanzapine, quetiapine, brexpiprazole, and lurasidone are Food and Drug Administration approved for the treatment of schizophrenia in adolescents. However, except for haloperidol, all pharmacological indications for this disorder in children under 13 years are off label. Although this practice it is not forbidden carries an additional risk. In the following article we will review the evidence of antipsychotics used for the treatment of schizophrenia in the pediatric population with the aim of synthesizing information with clinical applicability., Competing Interests: The authors have no conflicts of interest to declare, (CC BY NC ND)

In the paediatric population, paticulary in the field of child and adolescent psychiatry, off-label indications are the rule rather than the exception. This may occur when a drug is indicated for a pathology, age, route of administration or treatment length other than those described in the product label. Argentina, unlike other countries, has no explicit regulation on off-label prescribing. Therefore, the prescription of a medicine in a manner different from that approved by the National Administration of Medicines, Food and Medical Technology (ANMAT) does not have a regulatory framework regarding the conditions that must be met at the time of treatment. Although off-label use is not prohibited, it carries an additional risk. In order to encourage research in paediatrics, regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have introduced legislative reform. The following paper will review the current framework of the regulatory agencies that are relevant to the paediatric population and will analyse criteria to guide physicians in the rational use of off-label pharmacotherapy., Competing Interests: The authors have no conflicts of interest to declare., (Creative Commons BY-NC-ND 4.0)

Risperidone is an antipsychotic commonly used during pregnancy. Because it can cross the placental barrier, our objective was to evaluate its actions on the smooth muscle of the human umbilical artery (HUA). Risperidone preincubation (1-300 nmol/L for 20 minutes) produced a significant decrease in maximum force development induced by serotonin or histamine in HUA rings. When applied on top of stable contractions induced by these agonists risperidone produced quick relaxations (IC(50) = 1 nmol/L for serotonin and 72 nmol/L for histamine). Risperidone induced the contraction of vascular rings depolarized by 40 mmol/L extracellular K(+) but not in the case of 80 mmol/L K(+), suggesting inhibition of K(+) channels. The patch-clamp technique showed that risperidone (3 nmol/L) inhibited whole-cell K(+) currents in freshly isolated HUA smooth muscle cells. Our results are the first showing risperidone effects in human vascular smooth muscle and highlight that its use during pregnancy should be adequately monitored.

This study explores the effects of light maternal ethanol consumption during pregnancy on the appearance of minor malformations in neonates as well as on the contractile properties of their umbilical cord arteries (UCAs). Clinical external findings of newborns of women declaring light ethanol consumption during any period of their pregnancies [ethanol-exposed group (E group), n=79] were compared with those of nonexposed mothers [nonexposed to ethanol group (NE group), n=100]. Women who smoked or had any associated pathology were excluded. E group mothers consumed, on average, 200-250 mL ethanol/trimester (upper limit 700 mL/trimester). Sixty-six percent of the neonates in the E group presented at least one minor malformation (retromicrognathia and minor anomalies of the auricular/preauricular area were the more common), whereas only 16% of the NE group did (p=0.0000). The percentage of children exhibiting Apgar scores <7 was significantly greater in the E group (11% versus 2%, p=0.0119). UCAs from the E group developed significantly less contractile force (p<0.05) than those of the NE group when exposed to 1 microM serotonin (5-HT) or to a high K+ depolarizing solution. This difference persisted after inhibition of endothelial release of nitric oxide (NO) and prostacyclin. In conclusion, even light drinking should be considered a risk during pregnancy.