Evidence map›Paper›PMID 39147961›Full record

ArticleDrug safety2024

Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.

Michele Fusaroli, Stefano Polizzi, Luca Menestrina, Valentina Giunchi, Luca Pellegrini, Emanuel Raschi, Daniel Weintraub, Maurizio Recanatini, Gastone Castellani, Fabrizio De Ponti and 1 more

Abstract read
In one paragraph

Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Michele Fusaroli *Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. michele.fusaroli2@unibo.it.ORCID http://orcid.org/0000-0002-0254-2212
Stefano Polizzi *Unit of Medical Physics, Department of Medical and Surgical Sciences, University of Bologna, 40138, Bologna, Italy.
Luca Menestrina *Department of Pharmacy and Biotechnology, Alma Mater Studiorum-University of Bologna, Via Belmeloro 6, 40126, Bologna, Italy.
Valentina GiunchiPharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Luca PellegriniHertfordshire Partnership NHS University Foundation Trust, Highly Specialised OCD and BDD Service, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK.
Emanuel RaschiPharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Daniel WeintraubPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Maurizio RecanatiniDepartment of Pharmacy and Biotechnology, Alma Mater Studiorum-University of Bologna, Via Belmeloro 6, 40126, Bologna, Italy.
Gastone CastellaniUnit of Medical Physics, Department of Medical and Surgical Sciences, University of Bologna, 40138, Bologna, Italy.
Fabrizio De PontiPharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Elisabetta PoluzziPharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionImpulsivity induced by dopaminergic agents, like pramipexole and aripiprazole, can lead to behavioral addictions that impact on social functioning and quality of life of patients and families (e.g., resulting in unemployment, marital problems, anxiety). These secondary effects, interconnected in networks of signs and symptoms, are usually overlooked by clinical trials, not reported in package inserts, and neglected in clinical practice.

objectiveThis study explores the syndromic burden of impulsivity induced by pramipexole and aripiprazole, pinpointing key symptoms for targeted mitigation.

methodsAn event-event Information Component (IC) on the FDA Adverse Event Reporting System (FAERS) (January 2004 to March 2022) identified the syndrome of events disproportionally co-reported with impulsivity, separately for pramipexole and aripiprazole. A greedy-modularity clustering on composite network analyses (positive pointwise mutual information [PPMI], Ising, Φ) identified sub-syndromes. Bayesian network modeling highlighted possible precipitating events.

resultsSuspected drug-induced impulsivity was documented in 7.49% pramipexole and 4.50% aripiprazole recipients. The highest IC concerned obsessive-compulsive disorder (reporting rate = 26.77%; IC median = 3.47, 95% confidence interval [CI] = 3.33-3.57) and emotional distress (21.35%; 3.42, 3.26-3.54) for pramipexole, bankruptcy (10.58%; 4.43, 4.26-4.55) and divorce (7.59%; 4.38, 4.19-4.53) for aripiprazole. The network analysis identified delusional jealousy and dopamine dysregulation sub-syndromes for pramipexole, obesity-hypoventilation and social issues for aripiprazole. The Bayesian network highlighted anxiety and economic problems as potentially precipitating events.

conclusionThe under-explored consequences of drug-induced impulsivity significantly burden patients and families. Network analyses, exploring syndromic reactions and potential precipitating events, complement traditional techniques and clinical judgment. Characterizing the secondary impact of reactions will support informed patient-centered decision making.

Indexed as

Adverse Drug Reaction Reporting SystemsImpulsive BehaviorPramipexoleUnited States Food and Drug AdministrationAripiprazoleBayes TheoremDrug-Related Side Effects and Adverse ReactionsHumansUnited StatesAripiprazolePramipexole

Identifiers

PMID39147961
PMCPMC11554833

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.