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. 2018 Sep;74(9):1181-1184.
doi: 10.1007/s00228-018-2496-3. Epub 2018 Jun 3.

Tamoxifen and the risk of Parkinsonism: a case/non-case study

François Montastruc  1   2   3   4 , Farzin Khosrow-Khavar  5   6 , Sibylle de Germay  1   2   7 , Christel Renoux  5   6   8 , Vanessa Rousseau  2   3   4   7 , Geneviève Durrieu  2   3 , Marion Montastruc  9 , Olivier Rascol  1   2   4   10 , Agnès Sommet  1   2   4   7   10 , Maryse Lapeyre-Mestre  1   2   4   7   10 , Justine Benevent  1   2   3   7 , Jean-Louis Montastruc  11   12   13   14   15   16
Affiliations

Tamoxifen and the risk of Parkinsonism: a case/non-case study

François Montastruc et al. Eur J Clin Pharmacol. 2018 Sep.

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.

Keywords: Adverse drug reaction; Drug safety; Parkinsonism; Pharmacovigilance; Tamoxifen.

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