ADHD Drugs and Cardiovascular Risk
Abstract
On February 9, the Drug Safety and Risk Management Advisory Committee of the FDA voted to recommend a “black-box” warning describing the cardiovascular risks of stimulant drugs used to treat ADHD. Dr. Steven Nissen explains why the advisory committee took decisive action.
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The median of published sudden death rates in children is 1.2-1.3/100,000/year.
“The median of these published sudden death rates in children is at 1.2–1.3/100,000/year.”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [99]
Sudden death rates in children range from 0.8 to 8.5/100,000 patient-years.
“Sudden death rates range from 0.8 to 8.5/100,000 patient-years [20, 30, 98, 99, 159].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [99]
Sudden death occurs only rarely in the general paediatric population.
“In contrast to adults, sudden death occurs only rarely in the general paediatric population.”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [99]
When patient-years of prescribed medication were incorporated, the frequency of reported sudden death per year of ADHD therapy with methylphenidate, atomoxetine or amfetamines among children was 0.2-0.5/100,000 patient-years.
“the frequency of reported sudden death per year of ADHD therapy with methylphenidate, atomoxetine or amfetamines among children was 0.2–0.5/100,000 patient-years [99].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [99]
QTc prolongation (and sudden death and increased heart rate) have been reported with methylphenidate and dexamfetamine and with atomoxetine.
“QTc prolongation (and sudden death and increased heart rate) have been reported with methylphenidate and dexamfetamine [99] and atomoxetine [34].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [99]
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- Authors
- Nissen, S. E.
- Affiliations
- Cleveland Clinic (US)
- Corresponding author
- Nissen, Steven E.
- ORCID
- Nissen, Steven E.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2006-04-06
- Volume
- 354
- Issue
- 14
- Pages
- 1445-1448
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2032285255
- Cited by
- 331
- References
- 6
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 3 · 2023: 5 · 2022: 7 · 2021: 4 · 2020: 6 · 2019: 9 · 2018: 10 · 2017: 8 · 2016: 11 · 2015: 14 · 2014: 19 · 2013: 25 · 2012: 28
- FWCI
- 26.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- attention deficit hyperactivity disorder, stimulants, cardiovascular risk, black box warning, drug safety, cardiovascular adverse events
- MeSH terms
- Adult, Central Nervous System Stimulants, Appetite Depressants, Attention Deficit Disorder with Hyperactivity, Cardiovascular Diseases, Child, Death, Sudden, Drug and Narcotic Control, Female, Humans, Male, Phenylpropanolamine, Sympathomimetics, United States, United States Food and Drug Administration, Ephedra
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