Face-to-face: isotretinoin use and pregnancy outcome.

Isotretinoin has been used to treat severe acne for more than 40 years. There are no accurate data on the absolute risk of potential teratogenicity to all fetuses exposed to isotretinoin. According to current guidelines, isotretinoin should be discontinued at least 1 month before pregnancy. This study enrolled pregnant women who contacted the Clinical Pharmacology and Toxicology Unit for individual drug risk assessment between 2016 and 2020. Data on maternal characteristics and isotretinoin exposures were obtained at first consultation. After delivery, follow-up calls were conducted using a structured questionnaire. Of 2,323 pregnant women consulted, 1.3% (31/2,323) had systemic isotretinoin exposure during and before pregnancy. Of 31 prospectively followed pregnancies, eight terminated electively. Most elective terminations (7/8) were performed because of the fear of fetal malformation. The majority of continued pregnancies (16/23) resulted in healthy live birth. There were no major birth defects. In six pregnancies, intrauterine deaths (three first trimester, three second trimester) were reported. Cesarean section was performed in 70.5% (12/17) of all deliveries. The median gestational age at birth was 39, and no preterm births were reported. Local isotretinoin treatments in six cases were evaluated and presented additionally, and all babies were born healthy. Based on the results of this study, there was no evidence of major birth defect, mental disorder, or retinoid embryopathy associated with the use of isotretinoin in pregnancy. Not local use, but systemic exposure to isotretinoin is of great concern that results in pregnancy termination.

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.