Objectives To investigate the frequency with which sedation was reported in post-marketing surveillance studies of four second generation antihistamines: loratadine, cetirizine, fexofenadine, and acrivastine. Design Prescription-event monitoring studies. Setting Prescriptions were obtained for each cohort in the immediate post-marketing period. Subjects Event data were obtained for a total of 43 363 patients. Main outcome measure Reporting of sedation or drowsiness. Results The odds ratios (adjusted for age and sex) for the incidence of sedation were 0.63 (95% confidence interval 0.36 to 1.11; P = 0

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This study found no evidence of an increased risk of suicidal ideation during treatment with atomoxetine, compared to the period prior to starting treatment. Amongst age specific subgroups, this risk may change. Nonetheless, individual case assessment suggested a causal relationship in some patients, hence physicians need to be aware of the possibility of developing this event, and furthermore consider how best to detect it in this paediatric population. This study demonstrates the importance of combining quantitative statistical analyses with a qualitative case series assessment.

This study has shown that the treatment with pioglitazone was associated with a low incidence of hypoglycaemia. The factors possibly increasing the risk of hypoglycaemia were concomitant therapy with sulfonylurea or insulin and female gender.