Use of methylphenidate and reporting of valvular heart disease: global pharmacovigilance analysis in children and adults

Aim/Objective: To explore the association between the use of MPH and VHD reporting in children and adults. Methods: We performed a disproportionality analysis within the WHO global safety database (VigiBase) using data, since inception until March 6th 2024, from: i) full database and ii) different age groups (children/adolescents 6-17 years; adults 18-64 years). To avoid competition bias, safety reports with amphetamine-like appetite suppressants were excluded. Disproportionality was expressed using reporting odds-ratio (ROR) and its 95% confidence interval (CI). Results: Of 29,129 spontaneous reports with MPH, 23 (7.9 per 10,000 reports) VHD cases were identified, including 13 adults and 10 children. Most cases concerned injury on mitral valve. A disproportionate reporting was observed overall (ROR 1.6, 95% CI 1.1-2.4). Analysis according to age group found that disproportionality in VHD reporting was not found in children and adolescents (ROR 1.7, 95% CI 0.9-3.2) but in adults only (ROR 2.7, 95% CI 1.6-4.7). Furthermore, amongst MPH users only, VHD reporting was higher in adults compared to children (ROR 2.7, 95% CI 1.2-6.3). Conclusion: VHD reporting appears rare with MPH compared to other adverse events and is increased only in adults. Our findings support a potential safety signal of VHD in adults exposed to MPH. A risk in that population cannot be excluded, requiring further assessment.