The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs into the marketplace, based on the drug’s perceived benefit–risk relationship. The Anesthetic and Analgesic Drug Product Advisory Committee is composed of experts in anesthesiology, pain management, and biostatistics, as well as consumer and industry representatives, who meet several times annually to review new anesthetic-related drugs, those seeking new indications, and nearly every opioid-related application for approval. The following report describes noteworthy activities of this committee since 2017, as it has grappled, along with the Food and Drug Administration, to balance the benefit–risk relationships for individual patients along with the overarching public health implications of bringing additional opioids to market. All anesthesia advisory committee meetings since 2017 will be described, and six will be highlighted, each with representative considerations for potential new opioid formulations or local anesthetics.

Abuse-deterrent opioid formulations have been suggested as one way to decrease the abuse, addiction, and overdose of orally prescribed opioids. Ten oral opioid formulations have received abuse-deterrent labeling by the U.S. Food and Drug Administration (FDA). Their properties consist of physical and/or chemical means by which the pills resist manipulation and create a barrier to unintended administration, such as chewing, nasal snorting, smoking, and intravenous injection. In this review, we describe the mechanisms of abuse-deterrent technology, the types of premarketing studies required for FDA approval, the pharmacology of the currently approved abuse-deterrent opioid formulations, and the evidence for and against their influence on opioid abuse. We conclude that there is currently insufficient evidence to indicate that the availability of abuse-deterrent opioid formulations has altered the trajectory of opioid overdose and addiction; however, postmarketing studies are in their infancy, and novel deterrent formulations are continually being developed and submitted for marketing approval.

This review identifies disease states associated with malignant hyperthermia susceptibility based on genotypic and phenotypic findings, and a framework is established for clinicians to identify a potentially malignant hyperthermia–susceptible patient.

Background The initial presentation of malignant hyperthermia (MH) may begin in the postoperative period. However, the maximal latency period between the end of anesthesia care and the onset of postoperative MH is unknown. The authors hypothesized that this latency period is short and is not manifested by hyperthermia as the initial presenting sign. The authors sought to test this hypothesis and to describe the clinical characteristics of postoperative MH by analysis of suspected cases in the North American Malignant Hyperthermia Registry. Methods Of 528 possible or suspected cases of MH in the North American Malignant Hyperthermia Registry, the authors identified 64 possible reports of postoperative MH. The records were reviewed in detail by the authors, each of whom assigned a qualitative score of "likely," "not likely," "not enough information available," or "not applicable" (where MH was not the final definitive diagnosis). Postoperative MH was confirmed after a consensus meeting of the three senior authors who reviewed in detail all possible "likely" cases. Results The authors identified postoperative MH in 10 subjects. All received volatile agents and 5 also received succinylcholine. All demonstrated signs characteristic of acute MH, including generalized rigidity, hypercapnia and/or tachypnea, tachycardia, and hyperthermia. No subject demonstrated hyperthermia as the presenting sign. The latency period between the anesthesia finish time and the onset of a sign indicative of acute MH ranged from 0 to 40 min. Conclusions Postoperative MH is uncommon, occurring in 10 of 528 suspected MH cases (1.9%) reported to the North American Malignant Hyperthermia Registry. Postoperative MH began shortly after completion of the anesthetic care. Hyperthermia was not a presenting sign of MH.

Background Lateral positioning decreases upper airway obstruction in paralyzed, anesthetized adults and in individuals with sleep apnea during sleep. The authors hypothesized that lateral positioning increases upper airway cross-sectional area and total upper airway volume when compared with the supine position in sedated, spontaneously breathing children. Methods Children aged 2-12 yr requiring magnetic resonance imaging examination of the head or neck region using deep sedation with propofol were studied. Exclusion criteria included any type of anatomical or neurologic entity that could influence upper airway shape or size. T1 axial scans of the upper airway were obtained in the supine and lateral positions, with the head and neck axes maintained neutral. Using software based on fuzzy connectedness segmentation (3D-VIEWNIX; Medical Imaging Processing Group, University of Pennsylvania, Philadelphia, PA), the magnetic resonance images were processed and segmented to render a three-dimensional reconstruction of the upper airway. Total airway volumes and cross-sectional areas were computed between the nasal vomer and the vocal cords. Two-way paired t tests were used to compare airway sizes between supine and lateral positions. Results Sixteen of 17 children analyzed had increases in upper airway total volume. The total airway volume (mean +/- SD) was 6.0 +/- 2.9 ml in the supine position and 8.7 +/- 2.5 ml in the lateral position (P < 0.001). All noncartilaginous areas of the upper airway increased in area in the lateral compared with the supine position. The region between the tip of the epiglottis and vocal cords demonstrated the greatest relative percent change. Conclusions The upper airway of a sedated, spontaneously breathing child widens in the lateral position. The region between the tip of the epiglottis and the vocal cords demonstrates the greatest relative percent increase in size.