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 BParkinsonism^ 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. . . . . Keywords Tamoxifen Parkinsonism Adverse drug reaction Pharmacovigilance Drug safety Introduction breast cancer and risk of PD, mainly after long-term exposure [5–7]. The pharmacodynamic explanation of these findings Drug-induced Parkinsonism (DIP) is believed to be the second involves the well-known neuroprotective effects of estrogens cause of Parkinsonism
European Journal of Clinical Pharmacology – Springer Journals
Published: Jun 3, 2018
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