Anesthesia Exposure in Children: Practitioners Respond to the 2016 FDA Drug Safety Communication.

In December 2016, the US Food and Drug Administration (FDA) issued a drug safety warning stating that 11 commonly used anesthetic and sedative medications had potential neurotoxic effects when used in children under the age of 3 years and in pregnant women during the third trimester. A panel presentation at the sixth biennial Pediatric Anesthesia Neurodevelopmental Assessment (PANDA) symposium addressed the FDA announcement in a session entitled "Anesthesia Exposure in Children During Surgical and Non-Surgical Procedures: How Do We Respond to the 2016 FDA Drug Safety Communication?" Panelists included representatives from pediatric anesthesiology, obstetrics, pediatric surgery, and several pediatric surgical subspecialties. Each panelist was asked to address the following questions: How has the FDA labelling change affected your clinical practice including patient discussions, timing, and frequency of procedures? Has your professional society provided any guidelines for this discussion? Has there been any discussion of this topic at your national meetings? The panelists provided important perspectives specific to each specialty, which generated a lively discussion and a detailed response from the Deputy Director of the Division of Anesthesia and Addiction of the FDA describing the FDA procedures that led to this drug safety warning.

Serum cardiac troponin-I elevation in neonatal cardiac surgery is lesion-dependent.

OBJECTIVE: Serum cardiac troponin-I (cTn-I) is a marker for myocardial injury in adults that undergoes developmental isoform change. To determine its utility as a myocardial injury marker in neonates, the authors examined the perioperative pattern of cTn-I elevation in neonates undergoing surgical repair for hypoplastic left-heart syndrome (HLHS) and transposition of great arteries (TGA). DESIGN: A prospective cohort study. SETTING: The study was performed in a tertiary teaching hospital that is a major referral center for congenital cardiac surgery. PATIENTS: Forty-five neonates were enrolled, 17 with HLHS, 15 with TGA with intact septum (TGA + IVS), 8 with TGA with ventricular septal defect (TGA + VSD), and 5 neonates undergoing extracardiac surgery who did not require cardiopulmonary bypass (CPB). INTERVENTIONS: None. RESULTS: Preoperative cTn-I was elevated in all neonates undergoing cardiac surgery with CPB. Increases in postoperative cTn-I correlated with duration of aortic cross-clamp application and CPB. Peak elevation in serum cTn-I occurred between 6 and 24 hours postoperatively in all neonates after cardiac surgery. The perioperative pattern of cTn-I was different in TGA + VSD (peak cTn-I = 10.9 +/- 5.9 ng/mL) compared with HLHS (peak cTn-I = 4.62 +/- 3.4 ng/mL) and TGA + IVS (peak cTn-I = 4.46 +/- 3.5 ng/mL). CONCLUSION: It was found that perioperative elevations in serum cTn-I in neonates with TGA and HLHS were influenced by duration of aortic cross-clamp application, CPB, and the presence of VSD.