These results suggest that AZP (50-100 mg/day) does not triple the rate of birth defects; however, it is associated with lower birth weight, gestational age, and prematurity. Larger studies are needed to confirm these observations.

This study examines the association between trauma exposure and posttraumatic stress disorder (PTSD) among 157 help-seeking children (aged 8-17). Structured clinical interviews are carried out, and linear and logistic regression analyses are conducted to examine the relationship between PTSD and type of trauma exposure controlling for age, gender, and ethnicity. Confrontation with traumatic news, witnessing domestic violence, physical abuse, and sexual abuse are each significantly associated with PTSD. Witnessing a crime, being the victim of a crime, and exposure to accidents, fire, or disaster are not associated with PTSD. These findings underscore the association between interpersonal violence and childhood PTSD.

Aim To investigate glutathione and antioxidant status changes in erythrocytes from febrile children receiving repeated supratherapeutic paracetamol doses. Methods Fifty-one children aged 2 months to 10 years participated in the study. Three groups were studied: group 1 ( n = 24) included afebrile children who did not receive paracetamol; and groups 2 ( n = 13) and 3 ( n = 14) included children who had fever above 38.5 ∞ C for more than 72 h. Patients in group 2 received paracetamol at a dose of 50 ± 15 (30-75) mg kg -1 day -1 and those in group 3 received paracetamol above the recommended therapeutic dose, ie 107 ± 28 (80-180) mg kg -1 day -1 . A blood sample was taken for the measurement of liver transaminases, gammaglutamil transferase (GGT), reduced glutathione (GSH), glutathione reductase (GR), glutathione peroxidase (GPX), glutathione S-transferase (GST), superoxide dismutase (SOD) and antioxidant status. Results Aspartate aminotransferase activity in group 3 was higher than in the other groups ( P = 0.027). GSH, SOD and antioxidant status were significantly lower in group 3 compared with groups 1 and 2 (mean differences: for GSH 3.41 m mol gHb -1 , 95% confidence interval (CI) 2.10-4.72, and 2.15 m mol gHb -1 , 95% CI 0.65-3.65, respectively; for SOD 856 U min -1 gHb -1 , 95% CI 397-1316, and 556 U min -1 gHb -1 , 95% CI 30-1082, respectively; and for antioxidant status 0.83 mmol l -1 plasma, 95% CI 0.30-1.36, and 0.63 mmol l -1 plasma, 95% CI 0.02-1.24, respectively). GR activity was significantly lower in groups 3 and 2 in comparison with group 1 (mean differences 3.44 U min -1 gHb -1 , 95% CI 0.63-6.25, and 5.64 U min -1 gHb -1 , 95% CI 2.90-8.38, respectively). Using multiple regression analysis, paracetamol dose was found to be the only independent variable affecting GR, GST and SOD activities ( P = 0.007, 0.003 and 0.008, respectively). Conclusions In febrile children, treatment with repeated supratherapeutic doses of paracetamol is associated with reduced antioxidant status and erythrocyte glutathione concentrations. These significant changes may indicate an increased risk for hepatotoxicity and liver damage.

The aim of this study is to determine the extent of use of medications that have not been specifically licensed for use in children (unlicensed), or medications whose use is not in accordance with the conditions of their license (off-label), in neonates in a neonatal intensive care unit (NICU). Medications given to 105 neonates were prospectively reviewed every 2 weeks during a 4-month period. The assessment as to whether every medication prescribed was unlicensed or off-label for use in children was based on a number of reference sources. Five hundred and twenty-five series of medications were used, of which 310 (59%) were off-label and 87 (16%) were unlicensed. Ninety-eight neonates (93%) received at least one off-label medication. The major reason for prescribing off-label medications was a deviation from the recommended dosage or age of the patient. The reason for giving unlicensed medications was changes in the formulation of the medication. The use of off-label and unlicensed medications is common in neonates. In view of the gravity and problematic nature of the issue, international consensus is evolving to conduct clinical trials in neonates and infants, with regard to medications already on the market, and new medications.