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Cited by 324Pharmacovigilance and Adverse Drug ReactionsParkinson's Disease Mechanisms and TreatmentsSchizophrenia research and treatment

Reports of pathological gambling, hypersexuality, and compulsive shopping associated with dopamine receptor agonist drugs

Moore, Thomas J., Glenmullen, Joseph, Mattison, Donald R.·2014·JAMA Internal Medicine
DOI 10.1001/jamainternmed.2014.5262
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Abstract

IMPORTANCE: Severe impulse control disorders involving pathological gambling, hypersexuality, and compulsive shopping have been reported in association with the use of dopamine receptor agonist drugs in case series and retrospective patient surveys. These agents are used to treat Parkinson disease, restless leg syndrome, and hyperprolactinemia. OBJECTIVES: To analyze serious adverse drug event reports about these impulse control disorders received by the US Food and Drug Administration (FDA) and to assess the relationship of these case reports with the 6 FDA-approved dopamine receptor agonist drugs. DESIGN, SETTING, AND PARTICIPANTS: We conducted a retrospective disproportionality analysis based on the 2.7 million serious domestic and foreign adverse drug event reports from 2003 to 2012 extracted from the FDA Adverse Event Reporting System. MAIN OUTCOMES AND MEASURES: Cases were selected if they contained any of 10 preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) that described the abnormal behaviors. We used the proportional reporting ratio (PRR) to compare the proportion of target events to all serious events for the study drugs with a similar proportion for all other drugs. RESULTS: We identified 1580 events indicating impulse control disorders from the United States and 21 other countries:710 fordopamine receptor agonist drugs and 870 for other drugs. The dopamine receptor agonist drugs had a strong signal associated with these impulse control disorders (n = 710; PRR = 277.6, P < .001). The association was strongest for the dopamine agonists pramipexole (n = 410; PRR = 455.9, P < .001) and ropinirole (n = 188; PRR = 152.5, P < .001), with preferential affinity for the dopamine D3 receptor. A signal was also seen for aripiprazole, an antipsychotic classified as a partial agonist of the D3 receptor (n = 37; PRR = 8.6, P < .001). CONCLUSIONS AND RELEVANCE: Our findings confirm and extend the evidence that dopamine receptor agonist drugs are associated with these specific impulse control disorders. At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings.

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Authors
Moore, T. J., Glenmullen, J., & Mattison, D. R.
Affiliations
  • George Washington University (US)
  • Harvard University (US)
  • University of Ottawa (CA)
Corresponding author
Moore, Thomas J.
ORCID
Mattison, Donald R.
Venue
JAMA Internal Medicine
Publisher
American Medical Association (AMA)
Published
2014-12-01
Volume
174
Issue
12
Pages
1930
ISSN
2168-6106 (ISSN-L)
DOI
10.1001/jamainternmed.2014.5262
OpenAlex
W2106966901
Cited by
324
References
16
Citations by year
2026: 17 · 2025: 25 · 2024: 21 · 2023: 14 · 2022: 28 · 2021: 37 · 2020: 28 · 2019: 32 · 2018: 22 · 2017: 28 · 2016: 31 · 2015: 34 · 2014: 5 · 2012: 2
FWCI
24.48
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Neurology › Parkinson's Disease Mechanisms and Treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords
gambling addiction, hypersexuality, compulsive buying, impulse control disorders, dopamine agonists, pramipexole, ropinirole, aripiprazole, adverse drug reactions, disproportionality analysis, dopamine D3 receptor, Parkinson's disease, restless legs syndrome, hyperprolactinemia, drug safety warnings, FDA Adverse Event Reporting System, serious adverse drug reactions
MeSH terms
Aripiprazole, Pramipexole, Adult, Aged, Compulsive Behavior, Consumer Behavior, Drug Labeling, Female, Gambling, Humans, Hyperprolactinemia, Impulsive Behavior, Indoles, Male, Middle Aged, Parkinson Disease, Piperazines, Restless Legs Syndrome, Retrospective Studies, Sexual Behavior, United States, United States Food and Drug Administration, Quinolones, Dopamine Agonists, Receptors, Dopamine D3, Benzothiazoles

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