Thromboembolism and Oral Contraceptives During the COVID-19 Pandemic: A Disproportionality Analysis Within the Spanish Pharmacovigilance Database

Luis H Martín; María Sainz-Gil; Ester Navarro-García; Inés Salado-Valdivieso; Rosario Sanz-Fadrique

doi:10.1007/s40801-021-00282-3

Thromboembolism and Oral Contraceptives During the COVID-19 Pandemic: A Disproportionality Analysis Within the Spanish Pharmacovigilance Database

Drugs Real World Outcomes. 2022 Jun;9(2):211-218. doi: 10.1007/s40801-021-00282-3. Epub 2022 Feb 10.

Authors

Luis H Martín^{1

2

3}, María Sainz-Gil^{1

2

3}, Ester Navarro-García^{4

5}, Inés Salado-Valdivieso^{1

3}, Rosario Sanz-Fadrique^{1

2}

Affiliations

¹ Centre for Drug Safety (CESME), Faculty of Medicine, Valladolid University, Valladolid, Spain.
² Centre for Pharmacovigilance of Castilla y León, Valladolid, Spain.
³ Department of Cellular Biology, Histology and Pharmacology, Valladolid University, Valladolid, Spain.
⁴ Centre for Drug Safety (CESME), Faculty of Medicine, Valladolid University, Valladolid, Spain. ester.navarro@uva.es.
⁵ De La Plana University Hospital, Castellón, Spain. ester.navarro@uva.es.

Abstract

Background: Thromboembolic events (TEs) are known to be a severe complication for COVID-19. They are associated with a systemic inflammatory response syndrome with coagulation cascade activation.

Objective: The aim of this study was to determine a potential association between the COVID-19 pandemic and the increment of the risk of suspected TEs in women on systemic hormonal contraceptives (SHCs).

Patients and methods: This study utilised a case/non-case approach in the Spanish Pharmacovigilance Database, which includes more than 290,000 cases of suspected adverse drug reactions (ADRs). The reporting odds ratio (ROR) was calculated during an initial pandemic period in 2020 compared with a pre-pandemic period in 2019 and an additional control period in 2018.

Results: While there was a decreased number of ADR notifications for any medications and for any type of ADR in patients on SHCs during the pandemic period, the TE ROR for all SHCs was higher in the 2020 pandemic period [ROR = 11.8 (5.6-24.7)] relative to the pre-pandemic period in 2019 [ROR = 6.3 (3.2-12.5)] and the additional control period in 2018 [ROR = 4.6. (2.1-9.9)]. In contrast, ROR for progestogen-only contraceptives was lower during the pandemic as compared with the two control periods.

Conclusion: The reported disproportionality of TEs in women on SHCs rose during the pandemic period. This suggests a potential interaction of the drug (SHC) with COVID-19, which led to an increased risk of TEs in women exposed to both factors. This should be taken into consideration in the context of the COVID-19 pandemic.