Sleep disorders and hallucinations when using delamanid in children
From the WHO Global Drug Safety Database (Vigibase), signals of sleep disorders and hallucinations in children and adolescents have been detected with the use of delamanid. The association between the condition of sleep disorders (excluding isolated hallucinations) and the use of delamanid has been assessed at a level of “possible”.
-According to the WHO tuberculosis treatment guidelines, delamanid may be used in the treatment regimen for multidrug-resistant tuberculosis or rifampicin-resistant tuberculosis (MDR/RR-TB) in pediatric patients of all ages.-In the WHO Vigibase database, a total of 16 cases of sleep disorders and hallucinations have been recorded in children aged 3-13 years. Among these, 15 cases (94%) were assessed as serious. 9 cases (56%) were subjects in clinical trials. 8 cases (50%) used delamanid for prevention and 5 cases (42%) used delamanid for tuberculosis treatment.
-Sleep disorders are a common condition in children and can be difficult to distinguish from the unwanted effects of medication. In the above cases, the relationship between the sleep disorder (excluding isolated hallucinations) and the use of delamanid was assessed at a “possible” level, where the event disappeared upon discontinuation of the medication, but reusing the medication did not record this event. Asymmetry analysis found statistically significant asymmetry in the age group from 2 to 11 years; however, caution is needed when interpreting this result due to the need to consider factors such as concomitant medications, underlying disease prevalence, and the reporting of an event multiple times.
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The article references information from the National Center for Drug Information and Adverse Drug Reaction Monitoring Website
