A Postmarketing Pharmacovigilance Study of Fenfluramine: Adverse Event Data Mining and Analysis Based on the US Food and Drug Administration Public Data Open Project (openFDA)

IF 3.2 3区医学 Q2 CLINICAL NEUROLOGY

Pediatric neurology Pub Date : 2025-03-08 DOI:10.1016/j.pediatrneurol.2025.03.001

Tianyu Chen MNS , Qiying Chen BM , Yuezhen Zhang BM , Ting Liu BM

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引用次数: 0

Abstract

Background

A postmarketing analysis of the adverse events (AEs) associated with fenfluramine (FFA) was conducted using the US Food and Drug Administration's Open Public Data Program (openFDA).

Methods

The openFDA database was queried to retrieve FFA AE reports. Two algorithms, namely, the reporting odds ratio (ROR) and proportional reporting ratio, were employed for the purpose of detecting potential safety signals.

Results

From the openFDA data platform, a total of 6,269,521 AE reports were collected during the study period; the number of AE reports with FFA as the primary suspect was 2386. Of these, 1526 (63.96%) were reported by consumers or non–health professionals, 2009 (84.20%) were reported by the United States, 1053 (44.13%) were unknown indications, and serious AEs were reported in 1315 cases (55.11%). A total of 62 signals were generated. The top 10 signals included atonic seizures (ROR of 918.52, 95% confidence interval [CI]: 670.65-1257.99), seizure clusters (ROR of 787.02, 95% CI: 595.26-1040.56), mitral valve thickening (ROR of 773.94, 95% CI: 463.47-1292.38), pulmonary valve incompetence (ROR of 600.71, 95% CI: 432.09-835.13), echocardiogram abnormal (ROR of 417.13, 95% CI: 307.87-565.16), change in seizure presentation (ROR of 287.55, 95% CI: 214.81-384.91), tricuspid valve incompetence (ROR of 221.42, 95% CI: 179.68-272.84), aortic valve incompetence (ROR of 176.59, 95% CI: 131.89-236.45), tonic convulsion (ROR of 173.68, 95% CI: 110.28-273.54), and myoclonic epilepsy (ROR of 158.05, 95% CI: 102.60-243.46).

Conclusions

This study employed the openFDA database to identify safety signals associated with FFA, thereby offering significant insights for clinical monitoring and risk identification in patients undergoing FFA therapy.

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来源期刊

Pediatric neurology 医学-临床神经学

CiteScore

4.80

自引率

2.60%

发文量

176

审稿时长

78 days

期刊介绍： Pediatric Neurology publishes timely peer-reviewed clinical and research articles covering all aspects of the developing nervous system. Pediatric Neurology features up-to-the-minute publication of the latest advances in the diagnosis, management, and treatment of pediatric neurologic disorders. The journal''s editor, E. Steve Roach, in conjunction with the team of Associate Editors, heads an internationally recognized editorial board, ensuring the most authoritative and extensive coverage of the field. Among the topics covered are: epilepsy, mitochondrial diseases, congenital malformations, chromosomopathies, peripheral neuropathies, perinatal and childhood stroke, cerebral palsy, as well as other diseases affecting the developing nervous system.