Seeking FDA Support for Improved Epinephrine Administration in Neonatal Resuscitation. On behalf of the neonatal medical community, we strongly support the request for the FDA's consideration of appropriate approval pathway that would allow clearance of drug administration products that improve the safety of administering epinephrine during neonatal resuscitation. 
While we recognize that labeling for major epinephrine products currently sold in the U.S. do not include any neonatal resuscitation uses, epinephrine administration is recommended as the standard of care by current nationally recognized neonatal resuscitation guidelines and reflects long-standing (decades) standard clinical practice in neonatal care. In particular, the Neonatal Resuscitation Program (NRP), developed by the American Academy of Pediatrics and endorsed by leading resuscitation authorities, recommends weight-based dosing of intravenous epinephrine to neonates during cardiac arrest. Alternately, when vascular access is not yet available, as is often the case immediately following birth, weight-based dosing by endotracheal administration is an acceptable standard alternate route under the guidelines. 
While epinephrine administration to neonates as described above is current standard clinical practice, the preparation of weight-based doses for neonates is complicated by the necessary use of products originally designed for adults in fixed dose syringe packaging. Thus, simplifying and improving neonatal dosing and administration of epinephrine is urgently needed with an emphasis on reducing clinical errors in providing this life-saving and recommended treatment. 
We respectfully urge the FDA to consider an appropriate approval pathway for such products that takes into account the long-standing, real-world neonatal practice and supports the highest standard of care for newborns in critical settings.



FOR FURTHER INFORMATION EMAIL:  insight@seattlechildrens.org

CONTACT: Heather Cruz, NNP 360-888-6793