The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this paper.

Download full-text PDF

Source

Publication Analysis

Top Keywords

united kingdom
4
kingdom data
4
data deficiencies
4
deficiencies influencing
4
influencing fda
4
fda decisions
4
decisions fda
4
fda permanently
4
permanently removed
4
removed in-person
4

Similar Publications

Introduction: Cerebrovascular dysfunction plays a critical role in the pathogenesis of dementia and related neurodegenerative disorders. Recent omics-driven research has revealed associations between vascular abnormalities and transcriptomic alterations in brain vascular cells, particularly endothelial cells (ECs) and pericytes (PCs). However, the impact of these molecular changes on dementia remains unclear.

View Article and Find Full Text PDF

Impact of Frailty on Antihypertensive Treatment in Older Adults.

Hypertension

January 2025

The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Newtown, Australia (L.C., S.Y., N.E., M.W., T.L., Y.G., C.S.A., K.H., X.C., R.P.).

Background: The association between systolic blood pressure and all-cause mortality differs between frail and nonfrail individuals, highlighting uncertainties about the effectiveness of antihypertensive treatments in frail populations.

Methods: Using data from the SHEP trial (Systolic Hypertension in the Elderly Program), a baseline frailty index (FI), including 55 variables, was constructed. Fine-Gray subdistribution hazard models and Cox proportional hazards regression models were used to explore the association between baseline FI and the risks of stroke, cardiovascular disease, and all-cause death, as well as to examine whether the impact of antihypertensive treatment on these outcomes was modified by baseline FI.

View Article and Find Full Text PDF

Esmolol in persistent ventricular fibrillation/tachycardia with de-emphasised adrenaline - Introducing the REVIVE project.

Resusc Plus

January 2025

Hampshire & Isle of Wight Air Ambulance, F4 Adanac Park, Adanac Drive, Nursling, Southampton SO16 0BT, the United Kingdom of Great Britain and Northern Ireland.

View Article and Find Full Text PDF

Background: The mechanistic association between the hydraulic forces generated during contrast injection and the risk of coronary injury is poorly understood. In this study, we sought to evaluate whether contrast injections increase intracoronary pressures beyond resting levels and estimate the risk of hydraulic propagation of coronary dissections.

Methods: This is a prospective, single-arm, multicenter study that included patients with nonculprit, non-flow-limiting coronaries.

View Article and Find Full Text PDF

Introduction: Monitoring and evaluation of maternal and child nutrition programs typically concentrates on overall population-level results. There is limited understanding, however, of how intervention reach and expected outcomes differ among sub-populations, necessary insight for addressing inequalities. These analyses aim to determine if maternal exposure to social and behavior change (SBC) interventions is associated with scales of maternal practices (antenatal care, iron and folic acid in pregnancy, diet in pregnancy, postnatal care, iron and folic acid postpartum, and maternal dietary diversity) and child practices (institutional birth, health mothers' group participation, growth monitoring and promotion, early initiation of breastfeeding and infant and young child feeding) in Nepal, overall and by wealth, caste, and geography.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!