Use of methylphenidate and reporting of valvular heart disease: Global pharmacovigilance analysis in children and adults.
Pharmacoepidemiol Drug Saf
; 33(6): e5814, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38837561
ABSTRACT
INTRODUCTION:
Methylphenidate (MPH) is a common treatment of attention-deficit/hyperactivity disorder (ADHD). Concern has been raised regarding its cardiovascular safety, partly in relation with its micromolar affinity for the 5-HT2B receptor, whose activation may result in valvular heart disease (VHD).METHODS:
To explore the association between the use of MPH and VHD reporting, we performed a disproportionality analysis within the WHO global safety database (VigiBase) using data, since inception until March 6th 2024, from (i) the 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 VHD cases (7.9 per 10 000 reports) were identified, including 13 adults and 10 children. Most cases concerned injury on the 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 found in adults only (ROR 2.7, 95% CI 1.6-4.7) but not in children/adolescents (ROR 1.7, 95% CI 0.9-3.2). 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 in adults only. Our findings support a potential safety signal of VHD in adults exposed to MPH. A risk in that population cannot be excluded and requires further assessment.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Attention Deficit Disorder with Hyperactivity
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Databases, Factual
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Adverse Drug Reaction Reporting Systems
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Pharmacovigilance
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Heart Valve Diseases
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Central Nervous System Stimulants
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Methylphenidate
Limits:
Adolescent
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Adult
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Child
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Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
Pharmacoepidemiol Drug Saf
Year:
2024
Document type:
Article