Background: Although the lack of evidence of pharmacological treatment to treat COVID-19 in pregnancy, some clinicians considered the use of certain medications empirically in those with severe disease. Monitoring the safety of these pharmacological treatments, especially in the pregnant population is important due to the potential adverse effects that could appear in the maternal-fetal binomial.
Objectives: To investigate drug utilization patterns and to assess the safety profile of medications in hospitalized pregnant with severe COVID-19 disease in two hospitals of the social security of health of Peru.
Methods: We performed an observational, descriptive, and retrospective drug use study among hospitalized pregnant with severe and confirmed COVID-19 disease from April 2020 to July 2021. Patient demographics, clinical characteristics, trimester of pregnancy, drugs utilization, and medical conditions diagnosed during pregnancy were retrieved from electronic medical records and centralized in our database. We assessed the off-label use and the potential drug interactions were assessed as well per trimester. Finally, we identified ADR and evaluated the FDA pregnancy risk categories.
Results: A total of 138 pregnant women medical records were eligible for this study. The median age of pregnant women was 32 years (IQR 20-34 years) and 79% were hospitalized during the third trimester. All were exposed to at least one medication with a total of 119 drugs prescribed (114 were assessed and considered as off-label). Over 60% of the pregnant were exposed to dexamethasone, 52.9% to metamizole, 11,6% were administered azithromycin, 2.2% ivermectin, and 0.7% hydroxychloroquine. Ceftriaxone and enoxaparin were more used in the third trimester (p=0,001). Polypharmacy was common (70%) and we found that 76.8% were moderate interactions, and 25.3% were important interactions. The estimated incidence of ADRs was 3%. According to FDA pregnancy risk classification, the majority of pregnant were prescribed drugs from category C/D.
Conclusions: Off-label use of different pharmacological treatments for COVID-19 was given to treat severe COVID-19 disease in hospitalized pregnant women. Clinicians should be aware of the potential increased risk of ADRs using such drugs in pregnant infected by SARS-CoV-2. More than 50% of hospitalized pregnant women were administered metamizole during the third trimester of pregnancy, despite the fact that the use of this drug during this period is associated with fetotoxicity.
