European Journal of Clinical Pharmacology

, Volume 68, Issue 5, pp 857–865 | Cite as

Do Parkinson’s disease patients disclose their adverse events spontaneously?

  • Santiago Perez-Lloret
  • María Verónica Rey
  • Nelly Fabre
  • Fabienne Ory
  • Umberto Spampinato
  • Jean-Louis Montastruc
  • Olivier Rascol
Pharmacoepidemiology and Prescription



Underreporting of adverse drug reactions is common but has been rarely studied in Parkinson’s disease (PD).


To compare the prevalence of adverse events (AEs) in relation to antiparkinsonian drugs in PD patients using two different data collection methods: patient’s spontaneous reporting versus a predefined investigator-driven structured interview. Secondary objectives were to assess factors related to spontaneous reporting and to compare the rate of AE reporting in PD patients with that of a group of non-parkinsonian post-stroke patients.

Study design

Cross-sectional study.


Ambulatory, cognitively intact PD or post-stroke outpatients.



Outcome measures

Patients were first asked by means of an an open question to disclose any unpleasant effects in connection with their current medications that had occurred during the previous week. Afterwards, a predefined questionnaire listing the most common AEs known to be related to antiparkinsonian drugs was used to question the same patients in a systematic manner about the presence of any AE during the same week. Chronological and semiological criteria were used to classify the reported AEs as “unrelated” or “possibly/plausibly related” to the antiparkinsonian treatment.


A total of 203 PD and 52 post-stroke patients of comparable age and sex were recruited. Eighty-five PD and five post-stroke patients reported spontaneously at least one AE (42 vs. 10%, p < 0.01), while 203 PD and 47 post-stroke patients reported at least one AE following the structured questionnaire (100 vs. 90%, p < 0.001). In PD patients, there were a total of 112 spontaneously reported AEs as compared with 1,574 according to the structured questionnaire (7%). Spontaneous disclosure of AEs was associated with experiencing >2 AEs [OR = 1.2 (1.1–3.2)], logistic regression). Seventy-four percent of PD patients had ≥1 AE possibly/plausibly related to antiparkinsonian drugs.


Results showed that only 7% of AEs were reported spontaneously by patients, thus underscoring the importance of systematically asking about AEs in PD patients.


Parkinson’s disease Adverse drug reactions Pharmacological treatment Levodopa Dopamine agonists Underreporting Non-motor symptoms Motor fluctuations 


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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Santiago Perez-Lloret
    • 1
    • 3
    • 7
    • 2
  • María Verónica Rey
    • 1
    • 3
    • 2
  • Nelly Fabre
    • 4
  • Fabienne Ory
    • 1
    • 2
  • Umberto Spampinato
    • 5
    • 6
  • Jean-Louis Montastruc
    • 1
    • 2
  • Olivier Rascol
    • 1
    • 3
    • 2
  1. 1.Laboratoire de Pharmacologie Médicale et Clinique, INSERM U 1027 Equipe de PharmacoEpidémiologie, Faculté de Médecine Université de ToulouseToulouseFrance
  2. 2.Service de Pharmacologie Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de PharmacoEpidémiologie et d’Informations sur le Médicament Centre Hospitalier UniversitaireToulouseFrance
  3. 3.INSERM Centre d’Investigation Clinique CIC 9203ToulouseFrance
  4. 4.Service de Neurologie et Explorations Fonctionnelles du Système NerveuxCHU RangueilToulouseFrance
  5. 5.Department of NeurologyUniversity Hospital BordeauxBordeauxFrance
  6. 6.INSERM U862, Neurocentre MagendieBordeauxFrance
  7. 7.Department of Clinical Pharmacology, Faculty of MedicineUniversity of ToulouseToulouseFrance

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