Category: News

Clinicians and researchers from the Leeds Gastroenterology Institute (UK) have published a systematic review which has identified preliminary safety data for tofacitinib, filgotinib, upadacitininb, and ozanimod, small molecules used in the treatment of inflammatory bowel disease. More information is available here.

The final analysis of an international pregnancy registry of women with multiple sclerosis treated with dimethyl fumarate has recently been published. The findings demonstrated no adverse effect of dimethyl fumarate exposure on birth defect, preterm birth, and spontaneous abortion risks. More information is available here.

Researchers from TIS Berlin (Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy, Charité – Universitätsmedizin Berlin) have published an analysis of 484 first trimester valproate exposed pregnancies which investigates the effects of valproate dose and first trimester treatment discontinuation on the risks of spontaneous abortion and major birth defects. More information is available here.

Researchers from the IMI ConcePTION project have published an analysis investigating the ability of pregnancy pharmacovigilance data sources to map their datasets to the CDE recommendations framework. More information is available here. Photo by Mikhail Fesenko on Unsplash

Researchers from TIS Berlin have led an international collaborative ENTIS study investigating previously reported safety signals of increased risks for major congenital anomalies and impaired fetal growth following maternal modafinil use in pregnancy. Further information is available here. Photo by Gregory Pappas on Unsplash

Researchers from the University of California San Francisco have published population-based cohort study using data collected from the Kaiser Permanente Northern California insurance database which has investigated the risk of adverse neonatal outcomes following maternal cannabis use in pregnancy. More information is available here. Photo by Thought Catalog on Unsplash

Researchers from the Netherlands Pharmacovigilance Centre Lareb, including several ENTIS members, have published a study comparing infants’ birth defects as reported by mothers and general practitioners. More information is available here. Photo by CDC on Unsplash

Researchers from the MONEAD investigator group have published the results of a longitudinal study investigating associations between fetal anti-seizure medication (ASM) exposure and adaptive, behavioural or emotional, and neurodevelopmental disorder outcomes at 2, 3, and 4.5 years of age. More information is available here.

ENTIS members from the Berlin TIS (Embryotox) have published a comparative cohort study investigating pregnancy outcomes for pregnancies exposed to levetiracetam. More information can be found here.