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Safety profile of lithium in adolescents (12-17 years) with bipolar disorder: a disproportionality analysis using the World Health Organization pharmacovigilance database
Mémoire de Master / Thèse d'exercice   Open Access

Safety profile of lithium in adolescents (12-17 years) with bipolar disorder: a disproportionality analysis using the World Health Organization pharmacovigilance database

Sonya Koester
Masters , Université de Montpellier
29/10/2024

Résumé

Pediatric bipolar disorder Adverse drug reaction Troubles bipolaires -- Chez l'adolescent Lithium -- Emploi en thérapeutique Lithium -- Effets secondaires Pharmacovigilance Tolérance aux médicaments Psychiatry Lithium Organisation Mondiale de la Santé
Lithium is commonly recommended as a first-line treatment for adults with bipolar disorder and has shown significant efficacy in pediatric populations. However, its use remains limited in adolescents due to concerns about its safety profile. The authors aim to assess the safety and tolerability of lithium in adolescents aged 12-17 years with bipolar disorder, using data from the World Health Organization's pharmacovigilance database. Methods: the authors conducted a disproportionality analysis on adverse drug reactions reports involving adolescents prescribed lithium, compared to adolescents treated with antipsychotics or antiepileptics, and adults on lithium. Primary outcomes included the frequency of serious adverse events such as suicidal behavior, hypothyroidism, bradycardia, and renal syndromes. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated to quantify the risks. Results: a total of 32,506 cases were included in the analysis. The authors found that lithium use in adolescents was associated with a favorable safety profile, showing reduced odds of suicidal ideation, pain, diabetes weight gain and abnormal movements compared to adolescents treated with antipsychotics and antiepileptics. However, there were higher incidences of suicide attempts, self-harm, hypothyroidism, bradycardia, and renal syndromes. Overall, these adverse effects occurred at similar frequencies in adults. However, adolescents had significantly lower risks of completed suicide, cardiorespiratory arrest, and renal failure compared to adults. Conclusion: the results of this study are consistent with the existing literature, which is partly favorable to lithium and shows a safety profile for lithium in adolescents similar to that observed in adults, but with fewer lethal side effects. However, this study presents biases inherent to pharmacovigilance studies and the risk of under-reporting adverse effects.

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