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Multicenter Study
. 2025 Apr;39(2):e70002.
doi: 10.1111/fcp.70002.

Use and misuse of domperidone in patients living with Parkinson disease in France

Edouard Januel  1   2 , Jean Christophe Corvol  2 , Philippe Remy  3 , Wassilios G Meissner  4   5   6 , Claire Thiriez  7 , Aymeric Lanore  2 , Cecilia Bonnet  8   9 , Jean-Philippe Azulay  10 , Caroline Giordana  11 , David Maltete  12 , Solene Frismand  13 , Christine Tranchant  14 , Francois Sellal  15 , Alain Jager  16 , Matthieu Béreau  17 , Giovanni Castelnovo  18 , Anne Evelyne Vallet  19   20 , Maryse Lapeyre-Mestre  21 , Jean-Denis Turc  22 , Olivier Rascol  23 , Florence Tubach  1 ; DUMP study group
Affiliations
Multicenter Study

Use and misuse of domperidone in patients living with Parkinson disease in France

Edouard Januel et al. Fundam Clin Pharmacol. 2025 Apr.

Abstract

Context: After observing increased sudden death risk associated with domperidone use, the European Medicines Agency (EMA) imposed usage restrictions in 2014, limiting age (≤60 years), daily dose (≤30 mg/day), and duration (≤7 days). Nausea commonly occurs as an adverse effect of dopaminergic drugs in Parkinson's disease (PD) patients, with few alternative anti-emetic options. This study aimed to assess domperidone prescription patterns in French PD patients.

Methods: In this multicenter study, all consecutive PD patients from participating expert centers, hospitals, and private neurologists were included. We documented demographics, clinical data, comorbidities, domperidone use (indication, dose, and duration), and concurrent medications (related to PD or not). Domperidone misuse was assessed based on EMA guidelines.

Results: Between January and October 2021, 1579 patients from 16 centers (12 French PD expert centers, two general hospitals, and two private practice neurologists) were included. Among them, 109 (7%) received domperidone: 32 (29%) for nausea during apomorphine infusion, 71 (65%) for nausea during other dopaminergic therapies, and three (3%) for orthostatic hypotension. Domperidone misuse was found in 103 patients (95%): treatment duration >7 days (84%), age >60 years (79%), contraindicated drug interactions (6%), and contraindications due to cardiac comorbidity (5%). Only one patient exceeded the recommended dose (30 mg/day).

Conclusion: Domperidone is still prescribed in France for PD patients with dopaminergic-induced nausea, mostly disregarding EMA guidelines due to patient age (>60 years) and prolonged treatment (>7 days). Our study underscores the unmet need for managing gastrointestinal symptoms in PD, highlighting the inadequacy of EMA guidelines in this population.

Keywords: European Medicines Agency; Parkinson disease; domperidone; misuse; nausea.

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Conflict of interest statement

Edouard Januel: none; Jean Christophe Corvol: JCC has served in advisory boards for Alzprotect, Bayer, Biogen, Denali, Ferrer, Idorsia, iRegene, Prevail Therapeutic, Servier, Theranexus, and UCB; and received grants from Sanofi and the Michael J Fox Foundation outside the submitted work; Philippe Remy: none; Wassilios G. Meissner: Outside the present work, WGM has served as consultant for Lundbeck, Alterity, Servier, Inhibikase, and Takeda; Claire Thiriez: no financial disclosure; congress travel grant from Orkyn, Abbvie, Homeperf, Adelia, Asdia, and Ipsen, outside the submitted work; Aymeric Lanore: none; Cecilia Bonnet: none; Jean‐Philippe Azulay: Boards, congresses, and clinical trial funding from Aguettant, AbbVie, Boston Sc, Elivie, NHC, HAC Pharma, Medtronic, and Merz, outside the submitted work; Caroline Giordana: fees from Abbott and Abbvie Orion pharma; David Maltete: none; Solene Frismand: Abbvie, Ipsen board; congress travel grant by Elivie, outside the submitted work; Christine Tranchant: none related to this work; Francois Sellal: fees for scientific communications for Novartis Pharma, Sanofi, and Lilly; Alain Jager: none; Matthieu Béreau: M.B. reports grants from France Parkinson Foundation, reimbursement of travel expenses to scientific meetings from Asten, Boston Scientific, Elivie, and Medtronic; honoraria from AbbVie, Aguettan, Allergan, Asdia, and Merz Pharma for lecturing outside the submitted work; Giovanni Castelnovo: GC has served advisory boards Novartis, Biogen, Sanofi, Genzyme, Merck Serono, Abbvie, Merz, BMS, Alexion, Janssen, Ipsen, outside the submitted work; Anne Evelyne Vallet: congress travel grant from LFB, Abbvie, Novartis, and Lundbeck et Adelia, outside the submitted work; Maryse Lapeyre‐Mestre: none; Jean‐Denis Turc: none; Olivier Rascol: none related to this work; Florence Tubach: FT is the head of the Centre de Pharmacoépidémiologie (Cephepi) of the Assistance Publique – Hôpitaux de Paris and of the Clinical Research Unit of Pitié‐Salpêtrière hospital, both these structures have received unrestricted research funding and grants for the research projects handled and fees for consultant activities from a large number of pharmaceutical companies that have contributed indiscriminately to the salaries of its employees. Florence Tubach is not employed by these structures and did not receive any personal remuneration from these companies.

Figures

FIGURE 1
FIGURE 1
Total and type‐specific domperidone misuse percentages, among patients treated with domperidone. This figure outlines domperidone misuse among patients treated with domperidone following the EMA recommendations. Ninety‐five percent exhibited at least one misuse criterion, with 84% surpassing the recommended treatment duration (>7 days) and 79% being over 60 years old. Additionally, 1% exceeded the dose (>30 mg/day), 5% had cardiologic contraindications (history of cardiac arrhythmia, cardiac insufficiency, and/or familial history of sudden death), and 6% were on contraindicated co‐medications (escitalopram, citalopram, and hydroxyzine).
See this image and copyright information in PMC

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