Safety of pharmacological options for the management of COVID-19 in pregnant women: An Indian perspective

Abstract

Coronavirus disease 2019 (COVID-19) is a viral illness caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) presenting with pulmonary and extra-pulmonary manifestations. The first case was reported in Wuhan, China in December 2019 and it has rapidly progressed to the form of a pandemic. The presentation is mild in about 80 percent of the cases but the disease can also progress to a severe form of respiratory illness leading to acute respiratory distress syndrome (ARDS) and sometimes multi-organ failure, especially in people with other co-morbidities. Pregnant women also appear to be at a greater risk of acquiring a severe infection due to physiological changes during pregnancy. Many drugs with in vitro activity against the virus or an immunomodulatory effect have been considered for repurposing or have been tried as off-label drugs. The safety data regarding the use of newly approved or off-label or investigational drugs in pregnant women is limited and this poses a great challenge for clinicians. Therefore, it is important to know the utility and safety of the medications to avoid untoward adverse effects on pregnant women and fetuses. In this review, we aim to provide an overview of the approved, off-label, unlicensed, new and some promising pharmacological options for their use in the treatment of COVID-19 and the safety profile in pregnancy in an Indian scenario.

Pharmacological consideration of COVID-19 infection and vaccines in pregnancy

“…Consequently, the International Federation of Gynaecology and Obstetrics and the American College of Obstetricians and Gynaecologists (ACOG) have detailed inadequate data regarding low-dose aspirin usage for prophylaxis against placenta-mediated pregnancy hitches. 2…”

“…31 Favipiravir is an emergency drug in India, China, Russia, and Japan to treat COVID-19 infection. 2 The drug has shown delay in embryo development in animal studies and death of embryo in peri-and pre-implantation period. The available data and clinical trials show that favipiravir cannot be recommended in pregnant and lactating women.…”

365 Dias de pandemia de COVID-19 e a realidade brasileira: pesquisas e reflexões

“…Estudos observacionais demonstraram a segurança da azitromicina na gravidez sem aumento nos riscos de malformações fetais. Seu uso também parece ser seguro em mulheres lactantes (MANCHANDA et al, 2021) Azitromicina, administrada na dose de 500 mg diários por 3-5 dias, pode reduzir o risco de infecções adicionadas em excesso (RYAN et al, 2020).…”

“…Demonstrou atividade antiviral in vitro contra vários vírus de RNA e DNA, como HIV-1, vírus do Nilo Ocidental, febre-amarela, Zika vírus e vírus da influenza. A ação antiviral é pensada para bloquear a entrada de proteínas virais nas células hospedeiras, inibindo a importação do receptor e, finalmente, a redução da carga viral (de SARS-CoV-2) em aproximadamente 5.000 vezes em cultura de células vero in vitro 48 horas após a infecção (MANCHANDA et al, 2021;LÓPEZ et al, 2020). (MANCHANDA et al, 2021).…”

“…É categorizado na categoria C de gravidez pelo FDA. Estudos em animais realizados em ratos, coelhos e camundongos relataram neurotoxicidade fetal (MANCHANDA et al, 2021).…”