Program seeks Council approval for an initiative titled “Obstetric-Fetal Pharmacology Research Centers”.
Medication use in pregnancy has been increasing significantly over the past 3 decades and will continue to rise as many women choose to become pregnant at an older age leading to more subsequent pre-existing medical conditions that require pharmacotherapies.
Over 90% of clinically approved medications lack appropriate information on efﬁcacy, safety, teratogenicity and pharmacokinetics in pregnancy. Critical needs for an improved efficacy and safety during pregnancy remains a challenge for patients, physicians, and researchers.
Many women also take medications during lactation and most of the medications may get into milk which pose a potential risk to breastfed infants.
For example, the current opioid epidemic has increasingly affected pregnant women and their unborn/newborn babies. There remains an urgent need to continue and expand previous research efforts on medications used in pregnant and lactating women to evaluate their impact on these women, their developing fetus and infants.
The major objective of this initiative is to support multidisciplinary teams of basic/translational and clinical scientists to identify innovative research strategies in obstetric-fetal pharmacology with an ultimate goal of improving the safety and effectiveness of the drug treatment in pregnant and lactating women. Previous funding for these centers included trials on pravastatin dose escalation for the prevention of preeclampsia, buprenorphine pharmacokinetics and pharmacodynamics in pregnancy and optimizing SSRIs management for pregnant women with depression, which have substantially expanded our understanding of these medications used in pregnancy. However, much remains to be done to improve our understanding of the medications used in women during pregnancy and lactation to address this unmet medical need for safer and more effective pharmacotherapies.
This proposed concept is highly relevant to the NICHD and OPPTB’s mission on “improve the safety and efficacy of pharmacotherapeutics … for obstetric and pediatric populations”.
This proposed concept also aligns with the PRGLAC Task Force recommendation on “Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products use by pregnant women and lactating women”.
Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)
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