July 11 FDA Grand Rounds presents research into effects on fetus of exposure to prescribed opioids during early pregnancy

Addressing unmet public health needs in the perinatal space 

Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems

Thursday, July 11, 2019

12:00 p.m. - 1:00 p.m. EST

 

Register here for webcast (public attendees and FDA staff)

 

Presented by: 

Amy Inselman, PhD

Division of Systems Biology

Biomarkers and Alternative Models Branch

FDA’s National Center for Toxicological Research (NCTR)

 

About the Presentation:

FDA biologist Dr. Amy Inselman presents on FDA’s Perinatal Health Center of Excellence (PHCE).  The Center, established to coordinate research on unmet public health needs during the perinatal period, focuses on the health of the mother, premature infants, and newborns as well as development throughout childhood.

Many FDA-regulated products given to newborns and infants — or provided to pregnant mothers — haven’t been studied extensively in these populations.  This has left knowledge gaps about their safety, efficacy, or potential toxicity. This presentation will highlight a PHCE-funded project to investigate opioid-induced neural tube defects in a mouse model. This project seeks to clarify the link between maternal toxicity and embryo-fetal development following opioid exposure.  The results may improve health communications (i.e. label change) that would help pregnant women and healthcare practitioners make more informed decisions about the risk of opioid exposure during early development.

What you’ll learn from this FDA biologist: 

1. How FDA’s product centers are collaborating through the agency’s Perinatal Health Center of Excellence to tackle unique issues in the perinatal space and throughout early childhood, like off-label use of medical products in pregnant women, premature infants, and newborns, including newborn exposure to certain foods and prescribed opioids.
2. The effects on the fetus of exposure to prescribed opioids during early pregnancy.
3. What data gaps exist and how animal models can be used to study the role maternal toxicity may have on development of birth defects.
4. The potential research outcomes in this area on labelling of medical products consumed by pregnant women.