This article provides an abbreviated overview of the newly Federal Drug Administration (FDA)approved novel drugs of 2021-2022 with their respective approved indication(s). The FDA serves as the governing body that regularly evaluates and approves medications that will eventually be introduced to the market for routine use. These medications include both drugs that are the same or related to previously approved products (e.g., Extended indications of priorly approved medications) and novel drugs. By definition, a novel drug is an innovative product which serves to improve quality care in patient populations with unmet or advanced medical needs to overall advance patient care and public health. This article was employed to highlight medications that may be seen in practice and to heighten overall awareness of these new drugs. From January 1, 2021, through June 13, 2022, the FDA approved 66 drugs characterized as novel (Table 1). The four drugs highlighted in this article were selected based on potential inpatient and outpatient utility, disease-state prevalence, and overall innovative medicationbased treatment approaches. The four highlighted drugs are included in Table 2.
Background Due to the mechanisms of action of conventional catecholamine vasopressors, there is increased risk of renal allograft injury and adverse events in transplant recipients with fluid‐refractory distributive shock during the perioperative period. As such, mechanistically alternative vasopressors like angiotensin II (ATII) may avoid these complications, but there is an absence of data supporting use in this population. Methods This was a single‐center, single‐arm, open‐label, phase 4 study conducted as a 1‐year pilot of 20 adult renal transplant recipients receiving ATII as their first continuous infusion vasopressor in the perioperative period. The study aim was to systematically assess the safety and hemodynamic effects of ATII. Safety was assessed based on the incidence of adverse events. Hemodynamic effect was assessed by the achievement of per protocol hemodynamic goals (i.e., SBP ≥120 mmHg) and the need for adjunct vasopressors. Results Most cases involved deceased donors (70%), with a corresponding mean (SD) cold ischemia time of 14.7 (8.6) h. Over a surgery duration of 5.3 (1.2) h, subjects received 3.2 (2.0) L of total volume resuscitation prior to ATII initiation. No adverse events were directly related to ATII administration. Throughout this period, ATII was utilized for a median of 1.0 (IQR, 1.5) h intraoperatively (N = 7), 26.5 (IQR, 84.8) h postoperatively (N = 4), and 63.8 (IQR, 57.8) h in subjects who required ATII both intra‐ and postoperatively (N = 9). Only one of the 20 patients needed adjunct continuous infusion vasopressors in addition to ATII. Conclusions Based on the observations of this pilot study, ATII is a safe and effective vasopressor option for renal transplant recipients requiring perioperative hypotension reversal.
PCV15 and PCV20 received FDA approval in 2021. This article provides an overview of all pneumococcal vaccines - PPSV23, PCV13, PCV15, and PCV20 and their place in therapy. It provides a summary of pneumococcal disease burden in the U.S., vaccine spectrum of activity, indications, adult/pediatric dosing schedules, efficacy, and common adverse drug reactions.
This article provides a summary of the newly updated asthma and COPD treatment guidelines. The Global Initiative for Asthma (GINA) treatment guidelines were updated in 2022. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines were updated in 2023. Both the GINA and GOLD treatment guidelines are published by Science Committees composed of physicians from various countries; the Science Committees meet twice yearly to review published literature and update the guideline recommendations if necessary. The purpose of this article is to highlight some of the important updates to the GINA and GOLD treatment guidelines.
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