Methylphenidate for ADHD rejected from the WHO Essential Medicines List due to uncertainties in benefit-harm profile
Open accessAbstract
Attention deficit hyperactivity disorder (ADHD) is a common psychiatric disorder with estimated global prevalence rates between 3% and 5% in children and 2.5% in adults, depending on the classification system used. The psychostimulant methylphenidate is one of the most frequently used medications for ADHD. In this analysis article we describe shortly the evidence in the field, an application for inclusion of methylphenidate on the WHO Model List of Essential Medicines, the comments raised to the application and the WHO Expert Committee’s decision. The application of getting methylphenidate on the WHO list was overzealous in reporting potential benefits, without highlighting key uncertainties and harms. Decisions encompassing medicines candidate to the WHO Model List should not be based on speculation about potential benefits and should fully incorporate areas of uncertainties. Even though methylphenidate has been used for over 60 years, the evidence concerning the benefits of this medication in children, adolescents and adults with ADHD is uncertain. The decision of the committee was to not include methylphenidate in the WHO Model List of Essential Medicines ‘due to uncertainties in the estimates of benefit, and concerns regarding the quality and limitations of the available evidence for both benefit and harm’.
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Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults
Epstein, T., Patsopoulos, N. A., & Weiser, M. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005041.pub3 · Cited by 62 · see citing works
RetractedDiagnostic and Statistical Manual of Mental Disorders
American Psychiatric Association (2013) · doi:10.1176/appi.books.9780890425596 · Cited by 116,369 · see citing works
Subcommittee on Attention-Deficit/Hyperactivity Disorder, S. C. O. Q. I. A. M. (2011) · Pediatrics · doi:10.1542/peds.2011-2654 · Cited by 2,185 · see citing works
Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis
Simon, V., Czobor, P., Bálint, S., Mészáros, Á., & Bitter, I. (2009) · British Journal of Psychiatry · doi:10.1192/bjp.bp.107.048827 · Cited by 1,601 · see citing works
Wolraich, M. L., Hagan, J. F., Allan, C., Chan, E., Davison, D., Earls, M., Evans, S. W., Flinn, S. K., Froehlich, T., Frost, J., et al. (2019) · Pediatrics · doi:10.1542/peds.2019-2528 · Cited by 1,410 · see citing works
Cortese, S., Adamo, N., Del Giovane, C., Mohr-Jensen, C., Hayes, A. J., Carucci, S., Atkinson, L. Z., Tessari, L., Banaschewski, T., Coghill, D., et al. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30269-4 · Cited by 1,402 · see citing works
ADHD Comorbidity Findings From the MTA Study: Comparing Comorbid Subgroups
JENSEN, P. S., HINSHAW, S. P., KRAEMER, H. C., LENORA, N., NEWCORN, J. H., ABIKOFF, H. B., MARCH, J. S., ARNOLD, L. E., CANTWELL, D. P., CONNERS, C. K., et al. (2001) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/00004583-200102000-00009 · Cited by 974 · see citing works
Medication for Attention Deficit–Hyperactivity Disorder and Criminality
Lichtenstein, P., Halldner, L., Zetterqvist, J., Sjölander, A., Serlachius, E., Fazel, S., Långström, N., & Larsson, H. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1203241 · Cited by 611 · see citing works
The comorbidity of ADHD in the general population of Swedish school-age children
Kadesjö, B., & Gillberg, C. (2001) · Journal of Child Psychology and Psychiatry · doi:10.1111/1469-7610.00742 · Cited by 569 · see citing works
Epidemiology of Adhd in School-Age Children
Scahill, L., & Schwab‐Stone, M. (2000) · Child and Adolescent Psychiatric Clinics of North America · doi:10.1016/s1056-4993(18)30106-8 · Cited by 528 · see citing works
Epidemiology of attention-deficit/hyperactivity disorder across the lifespan
Polanczyk, G. V., & Rohde, L. A. (2007) · Current Opinion in Psychiatry · doi:10.1097/yco.0b013e3281568d7a · Cited by 483 · see citing works
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)
Storebø, O. J., Ramstad, E., Krogh, H. B., Nilausen, T. D., Skoog, M., Holmskov, M., Rosendal, S., Groth, C., Magnusson, F. L., Moreira-Maia, C. R., et al. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009885.pub2 · Cited by 347 · see citing works
Self-citationActive placebos versus antidepressants for depression
Moncrieff, J., Wessely, S., & Hardy, R. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003012.pub2 · Cited by 342 · see citing works
Storebø, O. J., Pedersen, N., Ramstad, E., Kielsholm, M. L., Nielsen, S. S., Krogh, H. B., Moreira-Maia, C. R., Magnusson, F. L., Holmskov, M., Gerner, T., et al. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012069.pub2 · Cited by 321 · see citing works
Self-citationChang, Z., Lichtenstein, P., D’Onofrio, B. M., Sjölander, A., & Larsson, H. (2014) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2013.4174 · Cited by 293 · see citing works
Raman, S. R., Man, K. K. C., Bahmanyar, S., Bérard, A., Bilder, S., Boukhris, T., Bushnell, G., Crystal, S., Furu, K., KaoYang, Y.-H., et al. (2018) · Lancet psychiatry · doi:10.1016/s2215-0366(18)30293-1 · Cited by 285 · see citing works
Zhang, S., Faries, D. E., Vowles, M., & Michelson, D. (2005) · International Journal of Methods in Psychiatric Research · doi:10.1002/mpr.7 · Cited by 257 · see citing works
Chang, Z., Quinn, P. D., Hur, K., Gibbons, R. D., Sjölander, A., Larsson, H., & D’Onofrio, B. M. (2017) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2017.0659 · Cited by 166 · see citing works
Developmental psychopathology: Attention Deficit Hyperactivity Disorder (ADHD)
Schmidt, S., & Petermann, F. (2009) · BMC Psychiatry · doi:10.1186/1471-244x-9-58 · Cited by 129 · see citing works
Side Effects and Placebo Amplification
Thomson, R. J. (1982) · The British Journal of Psychiatry · doi:10.1192/bjp.140.1.64 · Cited by 94 · see citing works
Matthijssen, A. M., Dietrich, A., Bierens, M., Deters, R. K., van de Loo-Neus, G. H. H., van den Hoofdakker, B. J., Buitelaar, J. K., & Hoekstra, P. J. (2019) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2019.18111296 · Cited by 81 · see citing works
AN EVALUATION OF THE DOUBLE‐BLIND DESIGN IN A STUDY COMPARING LITHIUM CARBONATE WITH PLACEBO
Marini, J. L., Sheard, M. H., Bridges, C., & Wagner, E. (1976) · Acta Psychiatrica Scandinavica · doi:10.1111/j.1600-0447.1976.tb00082.x · Cited by 40 · see citing works
Updated 2018 NICE guideline on pharmacological treatments for people with ADHD: a critical look
Faltinsen, E. G., Zwi, M., Cervelló, X. C., Gluud, C. N., Simonsen, E. H., & Storebø, O. J. (2018) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2018-111110 · Cited by 37 · see citing works
Self-citationExtended‐release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults
Boesen, K., Danborg, P., Gøtzsche, P., & Jørgensen, K. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012857 · Cited by 27 · see citing works
Storebø, O. J., Faltinsen, E. G., Zwi, M., Simonsen, E. H., & Gluud, C. N. (2018) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1149 · Cited by 25 · see citing works
Self-citationLasagna, L. C., & Meier, P. (1958) · Annual Review of Medicine · doi:10.1146/annurev.me.09.020158.002023 · Cited by 18 · see citing works
Risk of Bias and Quality of Evidence for Treatment of ADHD With Stimulant Medication
Swanson, J. M. (2018) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1186 · Cited by 9 · see citing works
Unbalanced risk-benefit analysis of ADHD drugs
Faltinsen, E. G., Gluud, C. N., Simonsen, E. H., et al. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30334-1 · Cited by 6 · see citing works
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Bahji, A. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13040999 · Cited by 83 · see citing works
“As a result, clinicians often approach the prescription of psychostimulants with caution, concerned about the potential for worsening substance use outcomes and the risk of mis-use [69,71].”
Background
- Authors
- Storebø, O. J., & Gluud, C.
- Affiliations
- University of Southern Denmark (DK)
- Corresponding author
- Storebø, Ole Jakob
- Venue
- BMJ Evidence-Based Medicine
- Publisher
- BMJ
- Published
- 2020-04-24
- Volume
- 26
- Issue
- 4
- Pages
- 172-175
- ISSN
- 1356-5524 (ISSN-L)
- 2515-446X
- 2515-4478
- OpenAlex
- W3020442651
- Cited by
- 13
- References
- 28
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2023: 1 · 2022: 3 · 2021: 3 · 2020: 1
- FWCI
- 1.47
- Type
- journal article
- Language
- en
- Open access
- Licence
- cc-by-nc
- Locations
- BMJ Evidence-Based Medicine (publishedVersion)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, cc-by-nc)
- Funders
- Psychiatric Research Unit, Region Zealand Psychiatry, Denmark
- Copenhagen Trial Unit, Centre for Clinical Intervention Research
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- methylphenidate, attention deficit hyperactivity disorder, WHO Model List of Essential Medicines, psychostimulants, quality of evidence, drug safety, children and adolescents
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