Exploring the potential association between stimulant or atomoxetine use and suicidal or self-injurious behaviors in children with attention deficit hyperactivity disorder: real-world insights from the FAERS database

Coghill D, Banaschewski T, Cortese S, Asherson P, Brandeis D, Buitelaar J, Daley D, Danckaerts M, Dittmann RW, Doepfner M, Ferrin M, Hollis C, Holtmann M, Paramala S, Sonuga-Barke E, Soutullo C, Steinhausen HC, Van der Oord S, Wong ICK, Zuddas A, Simonoff E (2023) The management of ADHD in children and adolescents: bringing evidence to the clinic: perspective from the European ADHD guidelines group (EAGG). Eur Child Adolesc Psychiatry 32:1337–1361. https://doi.org/10.1007/s00787-021-01871-x

Article  PubMed  Google Scholar 

Polanczyk GV, Willcutt EG, Salum GA, Kieling C, Rohde LA (2014) ADHD prevalence estimates across three decades: an updated systematic review and meta-regression analysis. Int J Epidemiol 43:434–442. https://doi.org/10.1093/ije/dyt261

Article  PubMed  PubMed Central  Google Scholar 

Cortese S, Holtmann M, Banaschewski T, Buitelaar J, Coghill D, Danckaerts M, Dittmann RW, Graham J, Taylor E, Sergeant J, European AGG (2013) Practitioner review: current best practice in the management of adverse events during treatment with ADHD medications in children and adolescents. J Child Psychol Psychiatry 54:227–246. https://doi.org/10.1111/jcpp.12036

Article  PubMed  Google Scholar 

Hennissen L, Bakker MJ, Banaschewski T, Carucci S, Coghill D, Danckaerts M, Dittmann RW, Hollis C, Kovshoff H, McCarthy S, Nagy P, Sonuga-Barke E, Wong IC, Zuddas A, Rosenthal E, Buitelaar JK, consortium A (2017) Cardiovascular effects of stimulant and non-stimulant medication for children and adolescents with ADHD: a systematic review and meta-analysis of trials of methylphenidate, amphetamines and atomoxetine. CNS Drugs 31:199–215. https://doi.org/10.1007/s40263-017-0410-7

Article  CAS  PubMed  PubMed Central  Google Scholar 

Reith DM, Edmonds L (2007) Assessing the role of drugs in suicidal ideation and suicidality. CNS Drugs 21:463–472. https://doi.org/10.2165/00023210-200721060-00003

Article  CAS  PubMed  Google Scholar 

Wei W, Chen L, Zhou H, Liu J, Zhang Y, Feng S, Bai Y, Leng Y, Chang E, Huang L (2023) Safety profiles of methylphenidate, amphetamine, and atomoxetine: analysis of spontaneous reports submitted to the food and drug administration adverse event reporting system. Front Pharmacol 14:1208456. https://doi.org/10.3389/fphar.2023.1208456

Article  CAS  PubMed  PubMed Central  Google Scholar 

Linden S, Bussing R, Kubilis P, Gerhard T, Segal R, Shuster JJ, Winterstein AG (2016) Risk of suicidal events with atomoxetine compared to stimulant treatment: a cohort study. Pediatrics 137:e20153199. https://doi.org/10.1542/peds.2015-3199

Article  PubMed  PubMed Central  Google Scholar 

Chen Q, Sjölander A, Runeson B, D’Onofrio BM, Lichtenstein P, Larsson H (2014) Drug treatment for attention-deficit/hyperactivity disorder and suicidal behaviour: register based study. BMJ 348:g3769. https://doi.org/10.1136/bmj.g3769

Article  CAS  PubMed  PubMed Central  Google Scholar 

Raschi E, Fusaroli M, Giunchi V, Repaci A, Pelusi C, Mollica V, Massari F, Ardizzoni A, Poluzzi E, Pagotto U, Di Dalmazi G (2022) Adrenal insufficiency with anticancer tyrosine kinase inhibitors targeting vascular endothelial growth factor receptor: analysis of the FDA adverse event reporting system. Cancers (Basel) 14:4610. https://doi.org/10.3390/cancers14194610

Article  CAS  PubMed  Google Scholar 

Morris R, Luboff H, Jose RP, Eckhoff K, Bu K, Pham M, Rohlsen-Neal D, Cheng F (2021) Bradycardia due to donepezil in adults: systematic analysis of FDA adverse event reporting system. J Alzheimers Dis 81:297–307. https://doi.org/10.3233/JAD-201551

Article  CAS  PubMed  Google Scholar 

Lee WJ, Lee TA, Pickard AS, Caskey RN, Schumock GT (2014) Drugs associated with adverse events in children and adolescents. Pharmacotherapy 34:918–926. https://doi.org/10.1002/phar.1455

Article  CAS  PubMed  Google Scholar 

Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A, De Freitas RM (1998) A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 54:315–321. https://doi.org/10.1007/s002280050466

Article  CAS  PubMed  Google Scholar 

Rothman KJ, Lanes S, Sacks ST (2004) The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidem Dr S 13:519–523. https://doi.org/10.1002/pds.1001

Article  Google Scholar 

Sakaeda T, Tamon A, Kadoyama K, Okuno Y (2013) Data mining of the public version of the FDA adverse event reporting system. Int J Med Sci 10:796–803. https://doi.org/10.7150/ijms.6048

Article  CAS  PubMed  PubMed Central  Google Scholar 

van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R, Egberts AC (2002) A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidem Dr S 11:3–10. https://doi.org/10.1002/pds.668

Article  CAS  Google Scholar 

Zhou J, Zheng Y, Xu B, Long S, Zhu LE, Liu Y, Li C, Zhang Y, Liu M, Wu X (2024) Exploration of the potential association between GLP-1 receptor agonists and suicidal or self-injurious behaviors: a pharmacovigilance study based on the FDA adverse event reporting system database. BMC Med 22:65. https://doi.org/10.1186/s12916-024-03274-6

Article  CAS  PubMed  PubMed Central  Google Scholar 

Merino D, Gérard AO, Destere A, Saidessalam H, Askenazy F, Montastruc F, Drici MD, Thümmler S (2024) Cardiac and metabolic safety profile of antipsychotics in youths: a WHO safety database analysis. Psychiat Res 334:115786. https://doi.org/10.1016/j.psychres.2024.115786

Article  CAS  Google Scholar 

Raschi E, Poluzzi E, Salvo F, Pariente A, De Ponti F, Marchesini G, Moretti U (2018) Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems. Nutr Metab Cardiovas 28:533–542. https://doi.org/10.1016/j.numecd.2018.02.014

Article  CAS  Google Scholar 

Li J, Wang Y, Yang X, Zhu H, Jiang Z (2024) Drug-induced hypoglycemia: a disproportionality analysis of the FAERS database. Expert Opin Drug Saf 23:1061–1067. https://doi.org/10.1080/14740338.2023.2278700

Article  CAS  PubMed  Google Scholar 

Zhang J, Guo Y, Wei C, Yan Y, Shan H, Wu B, Wu F (2024) A pharmacovigilance study of chronic kidney disease in diabetes mellitus patients with statin treatment by using the US food and drug administration adverse event reporting system. Front Pharmacol 15:1363501. https://doi.org/10.3389/fphar.2024.1363501

Article  CAS  PubMed  PubMed Central  Google Scholar 

Norén GN, Hopstadius J, Bate A (2013) Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery. Stat Methods Med Res 22:57–69. https://doi.org/10.1177/0962280211403604

Article  PubMed  Google Scholar 

Chen H, Yang G, Ma J (2024) Ocular toxicity associated with anti-HER2 agents in breast cancer: a pharmacovigilance analysis using the FAERS database. Int J cancer 154:1616–1625. https://doi.org/10.1002/ijc.34848

Article  CAS  PubMed  Google Scholar 

Zhou J, Wei Z, Xu B, Liu M, Xu R, Wu X (2022) Pharmacovigilance of triazole antifungal agents: analysis of the FDA adverse event reporting system (FAERS) database. Front Pharmacol 13:1039867. https://doi.org/10.3389/fphar.2022.1039867

Article  CAS  PubMed  PubMed Central  Google Scholar 

Shu Y, He X, Wu P, Liu Y, Ding Y, Zhang Q (2022) Gastrointestinal adverse events associated with semaglutide: a pharmacovigilance study based on FDA adverse event reporting system. Front Public Health 10:996179. https://doi.org/10.3389/fpubh.2022.996179

Article  PubMed  PubMed Central  Google Scholar 

Greydanus DE, Nazeer A, Qayyum Z, Patel DR, Rausch R, Hoang LN, Miller C, Chahin S, Apple RW, Saha G, Prasad Rao G, Javed A (2024) Pediatric suicide: review of a preventable tragedy. Dm-dis Mon 101725. https://doi.org/10.1016/j.disamonth.2024.101725

Junuzovic M, Lind KMT, Jakobsson U (2022) Child suicides in Sweden, 2000–2018. Eur J Pediatr 181:599–607. https://doi.org/10.1007/s00431-021-04240-7

Article  PubMed  Google Scholar 

McCarthy S, Wilton L, Murray ML, Hodgkins P, Asherson P, Wong IC (2012) The epidemiology of pharmacologically treated attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults in UK primary care. BMC Pediatr 12:78. https://doi.org/10.1186/1471-2431-12-78

Article  CAS  PubMed  PubMed Central  Google Scholar 

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