Latest news with #adverseevents
Medscape
2 days ago
- Health
- Medscape
Adverse Events in Airway Procedures in Kids: Key Risks
TOPLINE: Adverse events occurred in 2% of children who underwent procedures for airway management under general anesthesia, with higher rates in neonates and infants. Risk factors included younger age, the presence of anatomic difficulties, and undergoing anesthesia outside operating rooms. METHODOLOGY: Researchers conducted a prospective observational study at 10 tertiary care hospitals in Japan from June 2022 to January 2024, focusing on the incidence of adverse events during airway management in children under general anesthesia. A total of 16,695 children (mean age, 6.3 years; 41.4% girls; 1.8% neonates and 11.7% infants) received advanced airway management at least once under general anesthesia, with or without regional anesthesia, including tracheal intubation or the placement of a supraglottic airway device. Data on patient comorbidities, types of surgeries, training levels of anesthesia providers, and practices for airway management were collected. The primary outcome was the occurrence of adverse events related to airway management procedures during general anesthesia; the secondary outcome was desaturation, defined as a drop in oxygen saturation of at least 10%. Occurrences of any adverse events, including at least one hemodynamic and airway-related complication, and respiratory adverse events were recorded, and risk factors for adverse events and desaturation were identified. TAKEAWAY: Any adverse events occurred in 2% of cases of airway management, and desaturation was noted in 2.3% of cases. The incidence of any adverse events was 5.8% in neonates and 3.3% in infants, higher than that in preschool and school-going children and adolescents. Increasing age was linked to reduced odds of any adverse events (adjusted odds ratio [aOR], 0.92; P < .001). Insertion of a supraglottic airway device and the use of muscle relaxants at first attempt were also linked to reduced odds of any adverse events. Factors associated with increased odds of any adverse events included undergoing anesthesia in CT, MRI, or radiation therapy rooms (aOR, 5.7; P = .006); having airway sensitivity (aOR, 1.46; P = .010); and having one (aOR, 1.74; P = .042) or at least two (aOR, 2.82; P = .017) anatomic difficulties. The odds of desaturation decreased with increasing age (aOR, 0.78; P < .001) but were higher when anesthesia was provided in catheter labs and CT, MRI, or radiology therapy rooms than when provided in operating rooms. Airway management by nonspecialist anesthesiologists and trainees also was linked to higher odds of desaturation than when the intervention was performed by pediatric anesthetists. IN PRACTICE: 'Our study, focusing specifically on airway management, showed that approximately 21% of neonates and 7% of infants experienced desaturation, which was higher than that in other age groups,' the researchers reported. 'Neonates' unique physiological and anatomical characteristics can explain this hypoxic progression tendency…The higher desaturation incidence in neonates in our study highlights the necessity for shorter tracheal intubation time and higher first-attempt success rates in neonates,' they added. SOURCE: This study was led by Taiki Kojima, MD, MPH, of the Department of Anesthesiology at Aichi Children's Health and Medical Center in Obu, Japan. It was published online on July 07, 2025, in Anesthesiology. LIMITATIONS: The reliance on self-reported data from anesthesiologists may have introduced reporting bias and inaccuracies. Selection bias could have occurred due to missing cases, and unmeasured confounders may have affected the results. The exact incidence of adverse events by device type remained unclear due to multiple attempts with different devices. DISCLOSURES: The J-PEDIA study was funded by grants from the Ministry of Education in Japan. This study received Grants-in-Aid for Scientific Research from the Ministry of Education in Japan. No additional conflicts of interest were disclosed by the authors. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
ABC News
6 days ago
- Health
- ABC News
Queensland laws which would force IVF providers to notify authorities of 'serious adverse events' delayed six months
Queensland laws that would force IVF companies to notify authorities about "serious adverse events" — such as embryo mix-ups — will be delayed by six months to allow time for "consultation". Earlier this year, Monash IVF "voluntarily" told Queensland Health about a bungle at its Brisbane clinic, where a patient gave birth to a baby that was not genetically related to her. That case and another more recent embryo mix-up in Melbourne have put the national spotlight on IVF regulation. The next stage of Queensland's Assisted Reproductive Technology (ART) Act was meant to come into effect in September, however the Crisafulli government on Wednesday confirmed it will be deferred until March so it could "undertake proper consultation with stakeholders'. As well as mandatory "serious adverse event" notifications for providers, the laws would give Queensland Health the power to issue an improvement notice to ART providers to minimise health and safety risks. It would also allow authorities to place conditions on, as well as suspend or cancel, a provider's licence. Serious adverse events could involve "significant medical or surgical conditions" resulting from assisted reproductive treatment, breaches of law, or gamete or embryo identification mix-up, according to the bill's explanatory notes. The government said the decision to defer stage two of the laws from September to March was based on the advice from the chief health officer. "The six-month deferral will provide Queensland Health with sufficient time to consult on the draft ART Regulation 2025 that is required to operationalise the next stage of the Act," Health Minister Tim Nicholls said in a statement. His office foreshadowed likely amendments to the laws. The government said since the first stage of the act had come into force, some providers had paused IVF treatment for certain patients over concerns about meeting the new requirements. The ABC has previously reported on the case of one Queensland IVF patient who had to cancel her embryo transfer because it did not comply with the new laws, only to be later told she could go ahead with her treatment. The government also cited concerns about a lack of consultation before the laws passed. "When it comes to helping families experience the miracle of life, we must ensure the IVF industry is well-regulated while also resolving the major issues created by Labor rushing through laws," Mr Nicholls said. "This is a sensible pause while government works to get the regulation right. Families deserve clarity and care and that starts with proper consultation." Shadow Health Minister Mark Bailey was critical of the delay. He said the legislation followed what had already been "exhaustive" consultation over several months as well as an investigation by the Health Ombudsman. But a Queensland Health spokeswoman said delaying the implementation would give the department more time to consult with the donor-conceived community and fertility providers. "It is critical Queenslanders have confidence in assisted reproductive services and that [the] industry understands its obligations, which is why we must get the legislative reforms right," she said. "The revised implementation date does not change our commitment to prioritising the health and wellbeing of people accessing ART services. "We will continue to work closely with ART providers to ensure they have rigorous safeguards in place to identify and mitigate potential risks." Family creation lawyer Sarah Jefford said it was "not the time to be holding back on these reforms given there's already a lack of trust in the community towards fertility providers". She also said there should be an independent national framework for fertility providers. In June, the nation's health ministers agreed to a three-month rapid review of the IVF sector following the second Monash IVF bungle. Queensland Health said delaying the next stage of the laws would allow the department time to consider the outcomes of that national review.
Medscape
16-06-2025
- Health
- Medscape
Avelumab Plus Axitinib Shows Promise in Advanced GIST
Combination therapy with avelumab plus axitinib demonstrated a clinical benefit in patients with advanced gastrointestinal stromal tumour (GIST), achieving a 69.6% disease control rate and a 57.1% progression-free survival (PFS) rate at 3 months. METHODOLOGY: Researchers conducted a phase 2 trial to evaluate the safety and efficacy of avelumab in combination with axitinib among 56 patients with unresectable/metastatic GIST (median age, 60 years) after the failure of standard therapy. Participants received avelumab 10 mg/kg intravenously every 2 weeks combined with axitinib 5 mg orally twice daily. The primary endpoint was the 3-month PFS rate; key secondary endpoints included overall survival, disease control rate, duration of response, and adverse events (AEs). The median follow-up duration was 27.4 months. TAKEAWAY: The PFS rate at 3 months was 57.1%, the median PFS was 4.6 months, and the median overall survival was 14.2 months. A partial response was achieved in 8.9% of patients, and the median duration of response was 18.5 months. Stable disease was observed in 60.7% of patients, corresponding to a disease control rate of 69.6%. AEs occurred in 94.6% of patients, with 30.4% experiencing grade 3 or higher events. The most common treatment-related AEs were diarrhoea (33.9%), thyroid dysfunction (30.4%), hypertension (25%), palmar-plantar erythrodysesthesia (23.2%), myalgia (17.9%), and dysphonia (17.9%). IN PRACTICE: "The AXAGIST trial is the largest prospective study evaluating the efficacy of the combination of immune checkpoint inhibitor and a multikinase inhibitor in patients with advanced/metastatic GIST. These results provide unique data on the activity of axitinib in GIST patients, which in combination with avelumab, resulted in long-term clinical benefit in a significant subset of patients," the authors wrote. SOURCE: This study was led by Piotr Lukasz Rutkowski, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland. It was published online on June 06, 2025, in the European Journal of Cancer . LIMITATIONS: This study lacked a comparator arm, which made it impossible to conclude whether the addition of avelumab improves the antitumour activity of axitinib. DISCLOSURES: This research and drug supply were financially supported by Pfizer, as part of an alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc. Several authors declared receiving honoraria or having other ties with various sources.
Medscape
23-05-2025
- Health
- Medscape
Can Nivolumab Maintain AML Remission?
In a randomized phase 2 study of 79 patients with acute myeloid leukemia (AML) in first complete remission, nivolumab maintenance therapy did not improve progression-free survival (13.2 vs 10.9 months) or overall survival (53.9 vs 30.9 months) compared with observation. Adverse events were more frequent in the nivolumab arm, with 71% experiencing grade ≥ 3 events vs 12% in the observation arm. METHODOLOGY: A multicenter, open-label, randomized phase 2 trial enrolled 79 patients with AML in first complete remission or complete remission with incomplete hematologic recovery who were not candidates for stem cell transplant. Participants were randomized to either observation or nivolumab arm (3 mg/kg intravenously every 2 weeks for 46 doses), with a median follow-up duration of 24 months. Primary endpoint was progression-free survival, defined as time to disease relapse or death, while secondary endpoints included overall survival and evaluation of adverse events. Analysis included measurement of measurable residual disease (MRD) through ultrasensitive duplex DNA sequencing in 55 patients and targeted RNA sequencing in two patients before randomization. TAKEAWAY: Median progression-free survival duration was 13.2 months (95% CI, 8.5-21.8) in the nivolumab arm vs 10.9 months (95% CI, 5.4-14.9) in the observation arm (hazard ratio [HR], 0.92; 95% CI, 0.54-1.56; P = .38). = .38). Overall survival analysis showed median survival duration of 53.9 months (95% CI, 23.4 to not estimable) in the nivolumab arm vs 30.9 months (95% CI, 14.4 to not estimable) in the observation arm (HR, 0.78; 95% CI, 0.40-1.51; P = .23). = .23). Adverse events of grade ≥ 3 occurred in 71% of nivolumab-treated patients compared with 12% of patients in the observation arm ( P < .001), with fatigue (42%), hypertension (37%), and diarrhea (34%) being most common. < .001), with fatigue (42%), hypertension (37%), and diarrhea (34%) being most common. MRD positive patients showed significantly higher relapse rates at 2 years (74% vs 37%; P = .046) and decreased progression-free survival (21% vs 63%; P = .032) than MRD negative patients. IN PRACTICE: 'With negative results using checkpoint inhibitors alone (or in combination with HMA [hypomethylating agent]), now in both the MRD setting and in the front line, the utility of targeting the PD1-PDL1 [programmed cell death 1–programmed death ligand 1] pathway in unselected AML appears limited…. It remains possible that further correlatives studies might identify a subset of patients with AML who may responses to immune checkpoint inhibition,' wrote the authors of the study. SOURCE: The study was led by Athalia Pyzer and Hongtao Liu, The University of Chicago in Chicago. It was published online on May 13 in Blood Advances . LIMITATIONS: According to the authors, subgroup analysis in the cohort of MRD positive patients did not demonstrate any effect of nivolumab on clinical outcomes, but these comparisons were underpowered. The researchers noted that other immune escape mechanisms, even beyond checkpoint pathways, likely contribute to the persistence of this disease. DISCLOSURES: The study was supported by the Intramural Research Program of the National Heart, Lung, and Blood Institute, a University of Chicago Comprehensive Cancer Center pilot grant, the Ullman Scholar Award, and the Elsa U. Pardee Foundation. Additional disclosures are noted in the original article.
Washington Post
12-05-2025
- Health
- Washington Post
Digging into the math of a study attacking the safety of the abortion pill
The Ethics and Public Policy Center, a think tank that says it opposes 'the extreme progressive agenda while building consensus of conservatives,' recently issued a report on a key abortion medication, mifepristone, that it says raises questions about its safety. After analyzing insurance claims for more than 865,000 prescribed mifepristone abortions, the group said it had determined that almost 11 percent of women experienced a 'serious adverse event,' much higher than an overall 0.5 percent rate found in clinical studies.
