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 Ponti and Elisabetta Poluzzi
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Michele Fusaroli: University of Bologna
Stefano Polizzi: University of Bologna
Luca Menestrina: Alma Mater Studiorum-University of Bologna
Valentina Giunchi: University of Bologna
Luca Pellegrini: Hertfordshire Partnership NHS University Foundation Trust, Highly Specialised OCD and BDD Service
Emanuel Raschi: University of Bologna
Daniel Weintraub: University of Pennsylvania
Maurizio Recanatini: Alma Mater Studiorum-University of Bologna
Gastone Castellani: University of Bologna
Fabrizio Ponti: University of Bologna
Elisabetta Poluzzi: University of Bologna

Drug Safety, 2024, vol. 47, issue 12, No 8, 1275-1292

Abstract: Abstract Introduction Impulsivity 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. Objective This study explores the syndromic burden of impulsivity induced by pramipexole and aripiprazole, pinpointing key symptoms for targeted mitigation. Methods An 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. Results Suspected 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. Conclusion The 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.

Date: 2024
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DOI: 10.1007/s40264-024-01471-z

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