François Montastruc1,2,3,4, Farzin Khosrow-Khavar5,6, Sibylle de Germay1,2,7, Christel Renoux5,6,8, Vanessa Rousseau2,3,4,7, Geneviève Durrieu2,3, Marion Montastruc9, Olivier Rascol1,2,4,10, Agnès Sommet1,2,4,7,10, Maryse Lapeyre-Mestre1,2,4,7,10, Justine Benevent1,2,3,7, Jean-Louis Montastruc11,12,13,14,15,16. 1. Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, Université de Toulouse, 37 allées Jules-Guesde, 31000, Toulouse, France. 2. Service de Pharmacologie Médicale et Clinique, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. 3. Centre Régional de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. 4. NeuroToul Centre of Excellence in Neurodegeneration, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. 5. Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Québec, Canada. 6. Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Québec, Canada. 7. INSERM UMR 1027, Faculté de Médecine de Toulouse, Université de Toulouse, Toulouse, France. 8. Department of Neurology and Neurosurgery, McGill University, Montreal, Québec, Canada. 9. Institut Universitaire du Cancer Toulouse-Oncopôle, 1 avenue Irène-Joliot-Curie, 31059, Toulouse, France. 10. CIC INSERM 1436, Centre Hospitalier Universitaire de Toulouse, Université de Toulouse, Toulouse, France. 11. Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, Université de Toulouse, 37 allées Jules-Guesde, 31000, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 12. Service de Pharmacologie Médicale et Clinique, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 13. Centre Régional de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 14. NeuroToul Centre of Excellence in Neurodegeneration, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 15. INSERM UMR 1027, Faculté de Médecine de Toulouse, Université de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 16. CIC INSERM 1436, Centre Hospitalier Universitaire de Toulouse, Université de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr.
Abstract
BACKGROUND: Three studies have suggested a potential positive association between the use of tamoxifen in breast cancer and Parkinsonism, mainly after long-term exposure. OBJECTIVES: To explore this potential signal, we performed a case/non-case study using the World Health Organization Global Individual Case Safety Reports (ICSRs) database, VigiBase® between 1979 and 2018. METHODS: Among women ≥ 55 years, we measured the risk of reporting "Parkinsonism" compared with all other adverse drug reactions [as a reporting odds ratio (ROR 95% CI)] for tamoxifen compared to all other drugs or aromatase inhibitors. RESULTS: During the study period, 356 ICSRs of Parkinsonism reported with tamoxifen were identified. We failed to find a positive association between tamoxifen exposure and Parkinsonism in comparison with exposure to other drugs (ROR = 0.79; 95% CI 0.71-0.88) or aromatase inhibitors (ROR = 0.39; 95% CI 0.33-0.46). CONCLUSION: This study did not find evidence for Parkinsonism associated with tamoxifen.
BACKGROUND: Three studies have suggested a potential positive association between the use of tamoxifen in breast cancer and Parkinsonism, mainly after long-term exposure. OBJECTIVES: To explore this potential signal, we performed a case/non-case study using the World Health Organization Global Individual Case Safety Reports (ICSRs) database, VigiBase® between 1979 and 2018. METHODS: Among women ≥ 55 years, we measured the risk of reporting "Parkinsonism" compared with all other adverse drug reactions [as a reporting odds ratio (ROR 95% CI)] for tamoxifen compared to all other drugs or aromatase inhibitors. RESULTS: During the study period, 356 ICSRs of Parkinsonism reported with tamoxifen were identified. We failed to find a positive association between tamoxifen exposure and Parkinsonism in comparison with exposure to other drugs (ROR = 0.79; 95% CI 0.71-0.88) or aromatase inhibitors (ROR = 0.39; 95% CI 0.33-0.46). CONCLUSION: This study did not find evidence for Parkinsonism associated with tamoxifen.
Entities:
Keywords:
Adverse drug reaction; Drug safety; Parkinsonism; Pharmacovigilance; Tamoxifen
Authors: Francesco Salvo; Florent Leborgne; Frantz Thiessard; Nicholas Moore; Bernard Bégaud; Antoine Pariente Journal: Drug Saf Date: 2013-07 Impact factor: 5.606
Authors: René Zeiss; Christoph Hiemke; Carlos Schönfeldt-Lecuona; Bernhard J Connemann; Maximilian Gahr Journal: Drugs Real World Outcomes Date: 2021-06-11