Favipiravir exposure and pregnancy outcome of COVID-19 patients

Objective: COVID-19 is a rapidly spreading disease and many people have been infected in a short time. Favipiravir is under investigation for the treatment of COVID-19 and given to patients in many countries following emergency use approval. Based on data from animal studies, favipiravir use is contraindicated during pregnancy. Currently, there is no human data except for a single case report on use of favipiravir in pregnancy. Study design: This article includes the outcomes of 29 pregnancies reported to the Clinical Pharmacology and Toxicology Unit regarding favipiravir use in pregnancy. For drug risk assessment, maternal characteristics were obtained at first contact. After the expected day of delivery, follow-up is conducted by phone call and all relevant data regarding pregnancy and newborn outcome were documented. Results: Of the 29 pregnancies exposed to favipiravir, 5 were electively terminated and 24 resulted in live birth. There were no miscarriages or no stillbirths. There were 25 live births including one pair of twins. Three children were born premature, and one infant had patent foramen ovale. Birth weights, lengths and head circumferences of all infants were within normal range. Conclusion: The results of the study indicate that favipiravir is unlikely to be a major human teratogen, but experience is still limited for a well-grounded risk assessment. Although these findings may be useful for the physicians and patients, larger studies are needed due to small number of cases. (C) 2021 Published by Elsevier B.V.