Increase in thromboembolic ADRs from oral contraceptives during COVID-19 pandemic in Spain

Abstract

Increase in thromboembolic ADRs from oral contraceptives during COVID-19 pandemic in SpainA disproportionate increase in thromboembolic events (TEs) in women receiving oral systemic hormonal contraceptives (SHC) in Spain during the COVID-19 pandemic period "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", say researchers who published their findings in Drugs -Real World Outcomes.The Spanish Pharmacovigilance System Database (FEDRA) was searched for adverse drug reactions (ADRs) that were: spontaneous ADR notifications; females aged 15-50 years; involvement of SHC as the suspected drug; and, ADRs coded as MedDRA 'embolic and thrombotic events'. Reporting odds ratios were calculated comparing a COVID-19 pandemic period in 2020 versus a pre-pandemic period in 2019 and a control period in 2018. Disproportionality estimates were also calculated and compared with those for common control-drug ADRs (metamizole agranulocytosis and amoxicillin-clavulanic acid hepatotoxicity).During the pandemic period, there was a reduction in the number of ADR notifications for any medications and for any type of ADR in patients receiving SHCs; despite this, the TE reporting odds ratio (ROR) for all SHCs was higher in the 2020 pandemic period (11.8 [95% CI 5.6, 24.7]), compared with pre-pandemic 2019 period (6.3 [3.2, 12.5]) and the 2018 control period (4.6 [2.1, 9.9]). In contrast, the TE ROR for progestogen-only contraceptives was lower during the pandemic period, compared with the two control periods. All TE reports in both pre-pandemic and pandemic periods were considered severe. The profile of TEs differed between pandemic and pre-pandemic periods, with more cases of pulmonary embolism reported during the pandemic period (9/13 vs 4/12, respectively) but more cerebral thrombosis cases reported during the pre-pandemic period (5/12 vs 2/13).The researchers note that data on COVID-19 exposure was not available to include in the analysis to draw causal inferences; however, the results indicate "a need for this potential risk to be monitored", say the authors.