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1.
Vaccine ; 42(15): 3486-3492, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38704258

ABSTRACT

BACKGROUND: While safety of influenza vaccines is well-established, some studies have suggested potential associations between influenza vaccines and certain adverse events (AEs). This study examined the safety of the 2022-2023 influenza vaccines among U.S. adults ≥ 65 years. METHODS: A self-controlled case series compared incidence rates of anaphylaxis, encephalitis/encephalomyelitis, Guillain-Barré Syndrome (GBS), and transverse myelitis following 2022-2023 seasonal influenza vaccinations (i.e., any, high-dose or adjuvanted) in risk and control intervals among Medicare beneficiaries ≥ 65 years. We used conditional Poisson regression to estimate incidence rate ratios (IRRs) and 95 % confidence intervals (CIs) adjusted for event-dependent observation time and seasonality. Analyses also accounted for uncertainty from outcome misclassification where feasible. For AEs with any statistically significant associations, we stratified results by concomitant vaccination status. RESULTS: Among 12.7 million vaccine recipients, we observed 76 anaphylaxis, 276 encephalitis/encephalomyelitis, 134 GBS and 75 transverse myelitis cases. Only rates of anaphylaxis were elevated in risk compared to control intervals. With all adjustments, an elevated, but non-statistically significant, anaphylaxis rate was observed following any (IRR: 2.40, 95% CI: 0.96-6.03), high-dose (IRR: 2.31, 95% CI: 0.67-7.91), and adjuvanted (IRR: 3.28, 95% CI: 0.71-15.08) influenza vaccination; anaphylaxis IRRs were 2.54 (95% CI: 0.49-13.05) and 1.64 (95% CI: 0.38-7.05) for persons with and without concomitant vaccination, respectively. CONCLUSIONS: Rates of encephalitis/encephalomyelitis, GBS, or transverse myelitis were not elevated following 2022-2023 seasonal influenza vaccinations among U.S. adults ≥ 65 years. There was an increased rate of anaphylaxis following influenza vaccination that may have been influenced by concomitant vaccination.


Subject(s)
Influenza Vaccines , Influenza, Human , Vaccination , Aged , Aged, 80 and over , Female , Humans , Male , Anaphylaxis/epidemiology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Guillain-Barre Syndrome/epidemiology , Guillain-Barre Syndrome/etiology , Guillain-Barre Syndrome/chemically induced , Incidence , Influenza Vaccines/adverse effects , Influenza Vaccines/administration & dosage , Influenza, Human/prevention & control , Influenza, Human/epidemiology , Medicare/statistics & numerical data , Myelitis, Transverse/epidemiology , Myelitis, Transverse/etiology , Seasons , United States/epidemiology , Vaccination/adverse effects
2.
Allergol Immunopathol (Madr) ; 52(3): 8-16, 2024.
Article in English | MEDLINE | ID: mdl-38721950

ABSTRACT

BACKGROUND: Anaphylaxis proportions of incidence are increasing globally. However, limited data are available regarding anaphylaxis in the pediatric population of Greece. PURPOSE: The aim of the study was to evaluate management of anaphylaxis in Greek pediatric departments. METHODS: We performed a questionnaire-based study of children aged less than 16 years presenting with anaphylaxis in 10 national pediatric hospitals over a period of 2 years. Management of anaphylaxis was assessed prior to and after an informative intervention. RESULTS: In all, 127 cases of anaphylaxis were identified. Epinephrine was administered in almost half of all cases (51.2%), predominantly through intramuscular route (88.5%), while the majority of anaphylaxis patients were treated with antihistamines (92.9%) and corticosteroids (70.1%). Epinephrine was more likely administered by physicians if the elicitor was a drug (P < 0.003). Regarding long-term management, an epinephrine auto-injector was prescribed in 66.9% of patients. Follow-up information was available for most of the patients (92.9%), the majority of whom (76.3%) were referred to an allergist. More than half of these patients (63.6%) had a documented allergy follow-up, which identified a causative allergen in 53.3% of cases. No statistically significant differences were recorded prior to and after the intervention regarding management of anaphylaxis. CONCLUSIONS: This nationwide study highlighted the necessity of further improvement in terms of anaphylaxis treatment and secondary prevention measures. This presupposes appropriate education and training of healthcare professionals, thus contributing to proper and comprehensive care of the pediatric population.


Subject(s)
Anaphylaxis , Epinephrine , Humans , Anaphylaxis/epidemiology , Anaphylaxis/drug therapy , Anaphylaxis/therapy , Anaphylaxis/diagnosis , Greece/epidemiology , Child , Male , Female , Epinephrine/administration & dosage , Epinephrine/therapeutic use , Child, Preschool , Adolescent , Infant , Surveys and Questionnaires , Histamine Antagonists/therapeutic use , Histamine Antagonists/administration & dosage , Adrenal Cortex Hormones/therapeutic use , Adrenal Cortex Hormones/administration & dosage , Injections, Intramuscular
3.
J Korean Med Sci ; 39(8): e76, 2024 Mar 04.
Article in English | MEDLINE | ID: mdl-38442719

ABSTRACT

BACKGROUND: During coronavirus disease 2019 (COVID-19) pandemic, several COVID-19 vaccines were licensed with fast-track procedures. Although these vaccines have demonstrated high immunogenicity, there has been concerns on the serious adverse events (AEs) following COVID-19 vaccination among adolescents. We aimed to analyze comparative safety of COVID-19 vaccination in adolescents. METHODS: In this pharmacovigilance study, we performed a disproportionality analysis using VigiBase, the World Health Organization's global individual case safety report (ICSR) database. To compare serious AEs reported following COVID-19 vaccines vs. all other vaccines in adolescents aged 12-17 years, ICSRs following any vaccines on adolescents aged 12-17 years were included, defining cases as reports with the AEs of interest, with all other AEs as non-cases. The AEs of interest were myocarditis/pericarditis, multisystem inflammatory syndrome/Kawasaki disease (MIS/KD), anaphylaxis, Guillain-Barré syndrome (GBS), and immune thrombocytopenia (ITP). We conducted a disproportionality analysis to estimate reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE of interest, adjusted for sex by using logistic regression. RESULTS: Of 99,735 AE reports after vaccination in adolescents, 80,018 reports were from COVID-19 vaccinated adolescents (52.9% females; 56.3% America). The AEs of interest were predominantly reported as serious AE (76.1%) with mRNA vaccines (99.4%). Generally, higher reporting odds for the AEs were identified following COVID-19 vaccination in adolescents; myocarditis/pericarditis (2,829 reports for the COVID-19 vaccine vs. 35 for all other vaccines, adjusted ROR [aROR], 19.61; 95% CI, 14.05-27.39), and MIS/KD (104 vs. 6, aROR, 4.33; 95% CI, 1.89-9.88). The reporting odds for anaphylaxis (515 vs. 165, aROR, 0.86; 95% CI, 0.72-1.02), GBS (94 vs. 40, aROR, 0.64; 95% CI, 0.44-0.92) and ITP (52 vs. 12, aROR, 1.12; 95% CI, 0.59-2.09) were not significantly higher following COVID-19 vaccination. CONCLUSION: In this study, there were disproportionate reporting of immune-related AEs following COVID-19 vaccination. While awaiting definitive evidence, there is a need to closely monitor for any signs of immune-related AEs following COVID-19 vaccination among adolescents.


Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Guillain-Barre Syndrome , Mucocutaneous Lymph Node Syndrome , Myocarditis , Pericarditis , Purpura, Thrombocytopenic, Idiopathic , Adolescent , Female , Humans , Male , Anaphylaxis/epidemiology , Anaphylaxis/etiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Guillain-Barre Syndrome/epidemiology , Guillain-Barre Syndrome/etiology , Pharmacovigilance , Vaccination/adverse effects
5.
Allergy ; 79(5): 1317-1328, 2024 May.
Article in English | MEDLINE | ID: mdl-38462795

ABSTRACT

BACKGROUND: The epidemiology and management of anaphylaxis are not well-reported in Asia. METHODS: A regional pediatric anaphylaxis registry was established by the Asia-Pacific Research Network for Anaphylaxis (APRA), using standardized protocols for prospective data collection, to evaluate the triggers and management of anaphylaxis in the Asia-Pacific region. Pediatric patients below 18 years presenting with anaphylaxis across four Asian countries/cities (Thailand, Singapore, Hong Kong (HK), and Qingdao) were included. Allergen triggers, symptoms, anaphylaxis severity, and management were compared. RESULTS: Between 2019 and 2022, 721 anaphylaxis episodes in 689 patients from 16 centers were identified. The mean age at anaphylaxis presentation was 7.0 years (SD = 5.2) and 60% were male. Food was the most common trigger (62%), particularly eggs and cow's milk in children aged 3 years and below. In school-age children, nut anaphylaxis was most common in HK and Singapore, but was rare in the other countries, and wheat was the top allergen in Bangkok. Shellfish anaphylaxis was most common in children aged 7-17. Adrenaline was administered in 60% of cases, with 9% given adrenaline before hospital arrival. Adrenaline devices were prescribed in up to 82% of cases in Thailand but none in Qingdao. CONCLUSIONS: The APRA identified food as the main trigger of anaphylaxis in children, but causative allergens differed even across Asian countries. Fewer than two-thirds of cases received adrenaline treatment, pre-hospital adrenaline usage was low, and adrenaline device prescription remained suboptimal. The registry recognizes an unmet need to strengthen anaphylaxis care and research in Asia-Pacific.


Subject(s)
Anaphylaxis , Humans , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Anaphylaxis/therapy , Child , Male , Female , Child, Preschool , Asia/epidemiology , Adolescent , Food Hypersensitivity/epidemiology , Food Hypersensitivity/therapy , Infant , Allergens/immunology , Disease Management , Epinephrine/therapeutic use , Epinephrine/administration & dosage , Registries
6.
Br J Anaesth ; 132(6): 1230-1237, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38493055

ABSTRACT

BACKGROUND: Perioperative anaphylaxis is rare but is associated with significant morbidity. This complication has been well described in France by the GERAP (Groupe d'Etude des Réactions Anaphylactiques Périopératoires), a network focused on its study. The epidemiology of perioperative anaphylaxis is evolving, influenced by environmental factors and clinical practice. The aim of this study was to update the epidemiology of perioperative anaphylaxis in France. METHODS: This multicentre retrospective study was performed in 26 allergy clinics of the GERAP network in 2017-8. RESULTS: There were 765 patients with perioperative anaphylaxis included. Most cases were severe, with 428 (56%) reactions graded as 3 or 4 according to the Ring and Messmer classification. Skin test results were available for 676 patients, with a culprit agent identified in 471 cases (70%). Neuromuscular blocking agents were the main cause of perioperative anaphylaxis (n=281; 60%), followed by antibiotics (n=118; 25%) and patent blue dye (n=11; 2%). Cefazolin was the main antibiotic responsible for perioperative anaphylaxis (52% of antibiotic-related reactions). Suxamethonium and rocuronium were the main neuromuscular blocking agents responsible for perioperative anaphylaxis with 7.1 (6.1-8.4) and 5.6 (4.2-7.4) reactions per 100,000 vials sold, respectively, whereas cefazolin-related cases were estimated at 0.7 (0.5-0.9) reactions per 100,000 vials sold. CONCLUSIONS: Our results confirm that most commonly identified triggering agents remain neuromuscular blocking agents. Reactions to antibiotics, particularly cefazolin, are becoming increasingly frequent. The origin of sensitisation to cefazolin is unknown, as no cross-sensitisation has been described, and it should be the subject of further study. Perioperative anaphylaxis should be followed over the years and understood given the changing triggers. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT04654923).


Subject(s)
Anaphylaxis , Drug Hypersensitivity , Humans , Anaphylaxis/epidemiology , France/epidemiology , Retrospective Studies , Male , Female , Middle Aged , Adult , Aged , Drug Hypersensitivity/epidemiology , Neuromuscular Blocking Agents/adverse effects , Perioperative Period , Adolescent , Young Adult , Anti-Bacterial Agents/adverse effects , Aged, 80 and over , Skin Tests , Child
7.
Ital J Pediatr ; 50(1): 40, 2024 Mar 05.
Article in English | MEDLINE | ID: mdl-38439086

ABSTRACT

Anaphylaxis is a life-threatening reaction characterized by the acute onset of symptoms involving different organ systems and requiring immediate medical intervention. The incidence of fatal food anaphylaxis is 0.03 to 0.3 million/people/year. Most fatal food-induced anaphylaxis occurs in the second and third decades of life. The identified risk factors include the delayed use of epinephrine, the presence of asthma, the use of recreational drugs (alcohol, nicotine, cannabis, etc.), and an upright position. In the United Kingdom (UK) and Canada, the reported leading causal foods are peanuts and tree nuts. In Italy, milk seems to be the most common cause of fatal anaphylaxis in children < 18 years. Fatal food anaphylaxis in Italian children and adolescents almost always occurs outside and is characterized by cardiorespiratory arrest; auto-injectable adrenaline intramuscular was available in few cases. Mortality from food anaphylaxis, especially in children, is a very rare event with stable incidence, but its risk deeply impacts the quality of life of patients with food allergy and their families. Prevention of fatal food anaphylaxis must involve patients and their families, as well as the general public, public authorities, and patients' associations.


Subject(s)
Anaphylaxis , Asthma , Adolescent , Adult , Child , Humans , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Quality of Life , Epinephrine/therapeutic use , Arachis
8.
PLoS One ; 19(2): e0297902, 2024.
Article in English | MEDLINE | ID: mdl-38381729

ABSTRACT

BACKGROUND: To properly assess an association between vaccines and specific adverse events requires a comparison between the observed and background rates; however, studies in South Korea are currently limited. Therefore, in this study, we estimated the background incidence of anaphylaxis, myocarditis, pericarditis, Guillain-Barré syndrome (GBS), and mortality in South Korea. METHODS: A retrospective cohort study was conducted using the National Sample Cohort (NSC) data. Using NSC, the background incidence rate was estimated by dividing the number of episodes during 2009-2019 by the total population by year and then multiplying by 100,000. Using Statistics Korea data, the background mortality rate was estimated by dividing the number of deaths, during 2009-2019 by the standard population for that year and then multiplying by 100,000. Using background mortality rates, we predicted mortality rates for 2021 using autoregressive integrated moving average models. Further, the expected mortality rates were compared with observed mortality rates. RESULTS: The age-adjusted incidence rate (AIR) of anaphylaxis increased from 4.28 to 22.90 cases per 100,000 population (p = 0.003); myocarditis showed no significant increase, changing from 0.56 to 1.26 cases per 100,000 population (p = 0.276); pericarditis increased from 0.94 to 1.88 cases per 100,000 population (p = 0.005); and GBS increased from 0.78 to 1.21 cases per 100,000 population (p = 0.013). The age-adjusted mortality rate decreased from 645.24 to 475.70 deaths per 100,000 population (p <0.001). The 2021 observed/expected mortality rates for overall (ratio: 1.08, 95% confidence interval [CI]: 1.07-1.08), men (ratio: 1.07, 95% CI: 1.07-1.08), and women (ratio: 1.08, 95% CI: 1.07-1.09), were all significantly higher. When stratified by age group, those aged ≥80 (ratio: 1.16, 95% CI: 1.15-1.17), 60-69 (ratio: 1.11, 95% CI: 1.10-1.13), and 20-29 years old (ratio: 1.07, 95% CI: 1.02-1.13) were also significantly higher. CONCLUSION: Through the estimation of background rates related to anaphylaxis, myocarditis, pericarditis, GBS, and mortality, we established a reference point for evaluating the potential excess occurrence of adverse events following COVID-19 vaccination. This reference point serves as substantive evidence supporting the safety profile of COVID-19 vaccines.


Subject(s)
Anaphylaxis , COVID-19 Vaccines , Guillain-Barre Syndrome , Myocarditis , Pericarditis , Female , Humans , Male , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Cohort Studies , COVID-19/complications , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Guillain-Barre Syndrome/chemically induced , Guillain-Barre Syndrome/epidemiology , Incidence , Myocarditis/chemically induced , Myocarditis/epidemiology , Pericarditis/chemically induced , Pericarditis/epidemiology , Republic of Korea/epidemiology , Retrospective Studies , Vaccination/adverse effects
9.
J Clin Anesth ; 94: 111408, 2024 06.
Article in English | MEDLINE | ID: mdl-38387242

ABSTRACT

STUDY OBJECTIVE: We conducted this meta-analysis to summarize the available evidence and evaluate the relationship between a history of allergies/allergic diseases and perioperative anaphylaxis to offer preventive decision support. DESIGN: Systematic review and meta-analysis of observational studies. SETTING: We searched the MEDLINE (OVID), EMBASE, and the Cochrane Central Register of Controlled Trials databases for observational studies. Two investigators independently performed the search, screened the articles, and collected the study details. MEASUREMENTS: Several databases were systematically searched to evaluate the relationship between a history of allergies/allergic diseases and perioperative anaphylaxis using subgroup analysis, sensitivity analysis and meta-regression. MAIN RESULTS: A total of 19 studies involving 672 anaphylaxis episodes, 5608 immune-mediated reactions, and 1126 severe episodes met the eligibility criteria and were included in this meta-analysis. Drug allergies, food allergies, a history of allergies, and atopy increased the incidence of perioperative anaphylaxis (Drug allergies, odds ratio [OR] 3.54, 95% confidence interval [CI] 1.07-11.69; Food allergies, OR 2.29, 95% CI 1.23-4.26; A history of allergies, OR 4.86, 95% CI 3.65-6.49; Atopy, OR 3.58, 95% CI 1.47-8.71), but not the presence of immune-mediated reactions and the severity of perioperative anaphylaxis. CONCLUSIONS: Patients with previous drug allergies, food allergies, a history of allergies, or atopy are more likely to develop anaphylaxis during the perioperative period. Additional studies should be carried out to determine whether a history of allergies/allergic diseases is a major factor for perioperative anaphylaxis when confounders are controlled.


Subject(s)
Anaphylaxis , Drug Hypersensitivity , Food Hypersensitivity , Humans , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Food Hypersensitivity/epidemiology , Food Hypersensitivity/prevention & control , Drug Hypersensitivity/complications , Drug Hypersensitivity/epidemiology , Incidence , Perioperative Period
10.
Anaesthesia ; 79(5): 498-505, 2024 May.
Article in English | MEDLINE | ID: mdl-38205586

ABSTRACT

The 7th National Audit Project (NAP7) of the Royal College of Anaesthetists studied peri-operative cardiac arrest. Among 59 cases reported as possible anaphylaxis, 33 (56%) were judged to be so by the review panel with high or moderate confidence. Causes in excluded cases included: isolated severe hypotension; bronchospasm; and oesophageal intubation. Severe bronchospasm leading to cardiac arrest was uncommon, but notably in one case led to a reported flat capnograph. In the baseline survey, anaesthetists estimated anaphylaxis as the cause of 10% of cases of peri-operative cardiac arrests and to be among the four most common causes. In a year-long registry of peri-operative cardiac arrest, suspected anaphylaxis was the seventh most common cause accounting for 4% of reports. Initial management was most often with low-dose intravenous adrenaline, and this was without complications. Both the NAP7 baseline survey and case registry provided evidence of reluctance to starting chest compressions when systolic blood pressure had fallen to below 50 mmHg and occasionally even when it was unrecordable. All 33 patients were resuscitated successfully but one patient later died. The one death occurred in a relatively young patient in whom chest compressions were delayed. Overall, peri-operative anaphylaxis leading to cardiac arrest occurred with a similar frequency and patterns of presentation, location, initial rhythm and suspected triggers in NAP7 as in the 6th National Audit Project (NAP6). Outcomes in NAP7 were generally better than for equivalent cases in NAP6.


Subject(s)
Anaphylaxis , Bronchial Spasm , Heart Arrest , Humans , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Anaphylaxis/therapy , Epinephrine , Heart Arrest/etiology , Heart Arrest/therapy , Anesthetists
11.
Clin Exp Allergy ; 54(1): 11-20, 2024 01.
Article in English | MEDLINE | ID: mdl-38168878

ABSTRACT

Perioperative anaphylaxis (PA) is a severe condition that can be fatal, but data on PA mortality are scarce. The aim of this article is to review the epidemiology, elicitors and risk factors for PA mortality and identify knowledge gaps and areas for improvement regarding the management of severe PA. PA affects about 100 cases per million procedures. Mortality is rare, estimated at 3 to 5 cases per million procedures, but the PA mortality rate is higher than for other anaphylaxis aetiologies, at 1.4% to 4.8%. However, the data are incomplete. Published data mention neuromuscular blocking agents and antibiotics, mainly penicillin and cefazolin, as the main causes of fatal PA. Reported risk factors for fatal PA vary in different countries. Most frequently occurring comorbidities are obesity, male gender, cardiovascular diseases and ongoing treatment with beta-blockers. However, there are no clues about how these factors interact and the impact of individual risk factors. The pathophysiology of fatal PA is still not completely known. Genetic factors such as deficiency in PAF-acetyl hydrolase and hereditary alpha-tryptasemia, have been reported as modulators of severe anaphylaxis and possible targets for specific treatments. Our review underlines unmet needs in the field of fatal PA. Although we confirmed the need for timely administration of an adequate dose of adrenaline and the proper infusion of fluids, there is no evidence-based data on the proper dose of intravenous titrated adrenaline and which clinical manifestations would flag the need for fluid therapy. There are no large clinical studies supporting the administration of alternative vasopressors, such as glucagon and methylene blue. Further research on pathophysiological mechanisms of PA and its severity may address these issues and help clinicians to define new therapeutic approaches.


Subject(s)
Anaphylaxis , Humans , Male , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Epinephrine , Risk Factors , Cefazolin , Obesity/complications
13.
J Clin Anesth ; 94: 111377, 2024 06.
Article in English | MEDLINE | ID: mdl-38241788

ABSTRACT

STUDY OBJECTIVE: To compare the occurrence of cefazolin perioperative anaphylaxis (POA) in patients with and without a penicillin allergy label (PAL) to determine whether the prevalence of cefazolin POA differs based on the presence of a PAL. DESIGN: Cross-sectional study. SETTING: A large U.S. healthcare system in the Baltimore-D.C. region, July 2017 to July 2020. PATIENTS: 112,817 surgical encounters across inpatient and outpatient settings in various specialties, involving 90,089 patients. Of these, 4876 (4.3%) encounters had a PAL. INTERVENTIONS: Perioperative cefazolin administration within 4 h before surgery to 4 h after the procedure began. MEASUREMENTS: The primary outcome was cefazolin POA in patients with and without PALs. Potential POA cases were identified based on tryptase orders or diphenhydramine administrations within the initial cefazolin administration to 6 h postoperatively. Verification included two validation steps. The first checked for hypersensitivity reaction (HSR) documentation, and the second, led by Allergy specialists, identified POA and the probable culprit. The secondary outcome looked at cefazolin use trends in patients with a PAL, stratified by setting and specialty. MAIN RESULTS: Of 112,817 encounters, 1421 (1.3%) had possible cefazolin HSRs. Of these, 22 (1.5%) had POA, resulting in a 0.02% prevalence. Of these, 13 (59.1%) were linked to cefazolin and 9 (40.9%) attributed to other drugs. Only one cefazolin POA case had a PAL, indicating no significant difference in cefazolin POA prevalence between patients with and without PALs (p = 0.437). Perioperative cefazolin use in patients with PALs steadily increased from 2.6% to 6.0% between 2017 and 2020, specifically in academic settings. CONCLUSIONS: The prevalence of cefazolin POA does not exhibit significant differences between patients with and without PALs, and notably, the incidence remains remarkably low. Based on these findings, it is advisable to view cefazolin as an acceptable choice for prophylaxis in patients carrying a PAL.


Subject(s)
Anaphylaxis , Drug Hypersensitivity , Humans , Cefazolin/adverse effects , Anti-Bacterial Agents/adverse effects , Cross-Sectional Studies , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Anaphylaxis/prevention & control , Penicillins/adverse effects , Drug Hypersensitivity/epidemiology , Drug Hypersensitivity/etiology , Drug Hypersensitivity/drug therapy , Antibiotic Prophylaxis/adverse effects
14.
Yonsei Med J ; 65(2): 120-128, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38288652

ABSTRACT

PURPOSE: Following the withdrawal of propacetamol in Europe owing to safety issues, the regulatory authority of South Korea requested a post-marketing surveillance study to investigate its safety profile. MATERIALS AND METHODS: We conducted nested case-control and case-time-control (CTC) analyses of cases and controls identified for outcomes of interest, including anaphylaxis, thrombosis, and Stevens-Johnson syndrome (SJS), using the claims database of South Korea, 2010-2019. Risk-set sampling was used to match each case with up to 10 controls for age, sex, cohort entry date, and follow-up duration. Exposure to anaphylaxis, thrombosis, and SJS was assessed within 7, 90, and 30 days of the index date, respectively. We calculated odds ratios (OR) with 95% confidence intervals (CIs) using conditional logistic regression to assess the risk of outcomes associated with propacetamol. RESULTS: We identified cases of anaphylaxis (n=61), thrombosis (n=95), and SJS (n=1) and matched them to controls (173, 268, and 4, respectively). In the nested case-control analysis, the ORs for anaphylaxis and SJS were inestimable given the small number of propacetamol users during the risk period; meanwhile, the OR for thrombosis was 1.60 (95% CI 0.71-3.62). In the CTC design, the effect estimate was only estimated for thrombosis (OR 0.56, 95% CI 0.09-3.47). CONCLUSION: In both nested case-control and CTC analyses, propacetamol was not associated with an increased risk of anaphylaxis, thrombosis, or SJS. The findings from this study, which used routinely collected clinical data, provide reassuring real-world evidence regarding the safety of propacetamol in a nationwide population to support regulatory decision-making.


Subject(s)
Anaphylaxis , Stevens-Johnson Syndrome , Thrombosis , Humans , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Case-Control Studies , Acetaminophen/adverse effects , Stevens-Johnson Syndrome/etiology , Thrombosis/complications
15.
J Allergy Clin Immunol Pract ; 12(3): 670-680, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38182097

ABSTRACT

BACKGROUND: Evidence suggests that children who had received an initial priming dose of whole-cell pertussis (wP) vaccine, rather than acellular pertussis (aP) vaccine, had a lower risk of developing IgE-mediated food allergy, the most common cause of anaphylaxis-related hospital presentations of childhood. OBJECTIVE: To assess the association between wP versus aP vaccination in infancy and subsequent hospital presentations for anaphylaxis. METHODS: This study was preregistered under PMID 34874968. Perinatal records for a cohort of New South Wales-born children (1997-1999) receiving their first dose of pertussis-containing vaccine before age 4 months were probabilistically linked to hospital and immunization records. We used adjusted Cox models to estimate hazard ratios (aHRs) and 95% CIs for anaphylaxis-coded hospitalizations. RESULTS: There were 218,093 New South Wales-born children who received a first dose of wP or aP before age 4 months. Among these children, 86 experienced at least one hospitalization for food-induced anaphylaxis at age 5-15 years (range of events per patient, one to three). The person-time of follow-up was 1,476,969 years, and 665,519 years for children vaccinated with wP as a first dose (wP-1 children) and aP as a first dose (aP-1 children), respectively. The incidence rates for first hospitalization for food anaphylaxis were 3.5 (95% CI, 2.6-4.6) and 5.1 (95% CI, 3.5-7.1) per 100,000 child-years among wP-1 children and aP-1 children, respectively (aHR for wP vs aP = 0.47; 95% CI, 0.26-0.83). For first admission for venom anaphylaxis, the incidence rate was 4.9 (95% CI, 3.9-6.2) per 100,000 child-years among wP-1 children and 5.1 (95% CI, 3.5-7.1) per 100,000 child-years among aP-1 children (aHR for wP vs aP = 0.92; 95% CI, 0.53-1.60), and for all-cause anaphylaxis, the incidence rate was 10.6 (95% CI, 9.0-12.4) per 100,000 child-years among wP-1 children and 12.8 (95% CI, 10.2-15.8) per 100,000 child-years among aP-1 children (aHR for wP vs aP = 0.92; 95% CI, 0.53-1.60). CONCLUSION: Vaccination with wP in infancy was associated with a lower risk of hospitalizations for food-induced anaphylaxis (and therefore severe IgE-mediated food allergy) occurring in childhood.


Subject(s)
Acetazolamide/analogs & derivatives , Anaphylaxis , Food Hypersensitivity , Tetracyclines , Whooping Cough , Infant , Humans , Child, Preschool , Whooping Cough/prevention & control , Anaphylaxis/epidemiology , Cohort Studies , Transcription Factor AP-1 , Immunization, Secondary , Pertussis Vaccine , Vaccination , Food Hypersensitivity/epidemiology , Hospitalization , Immunoglobulin E
16.
Intern Med J ; 54(2): 265-273, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37461369

ABSTRACT

BACKGROUND: Anaphylaxis is a severe, potentially fatal, systemic allergic reaction. Understanding predictors of recurrent and severe anaphylaxis in adults, and identifying gaps in ongoing anaphylaxis care, is needed to minimise its impact. AIMS: To evaluate the risk factors in adults with severe and recurrent anaphylaxis presentations and to evaluate the management of patients in regard to the recommended cascade of care. METHODS: We completed a retrospective audit of adults with confirmed anaphylaxis who presented to an inner-city emergency department from 1 January 2009 through 31 December 2018. Data recorded included demographics, background history, medication use, severity, co-factors, triggers, management, discharge disposition and referral for follow-up. Data were managed in REDCap and analysed using Stata. Associations were assessed through odds ratios (ORs) and t tests. RESULTS: Six hundred sixteen individuals had 689 episodes of anaphylaxis over the audit period. Age over 65 (OR: 5.4 (95% confidence interval, CI: 2.3-13.2), P < 0.0001) and history of asthma (OR: 1.6 (95% CI: 1.03-2.5), P = 0.03) were independent risk factors for severe anaphylaxis. History of food allergy (P < 0.001) and food as the trigger were associated with recurrent presentations (OR: 2.1, 95% CI: 1.1-3.9, P = 0.01). Only 19% of patients met the recommended cascade of care, with post-adrenaline monitoring and recommending follow-up with an allergy specialist demonstrating the largest gaps. There were increased presentations with time but no difference in triggers or severity. CONCLUSIONS: Increased age and asthma were identified as risk factors for severe presentations. History of food allergy was a risk factor for recurrent presentations. Further research is needed on the gaps in care for adults with anaphylaxis to identify the reasons why, so we can better care for these patients.


Subject(s)
Anaphylaxis , Asthma , Food Hypersensitivity , Adult , Humans , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , Anaphylaxis/therapy , Retrospective Studies , Food Hypersensitivity/complications , Food Hypersensitivity/diagnosis , Food Hypersensitivity/epidemiology , Epinephrine/therapeutic use , Emergency Service, Hospital , Asthma/complications
17.
Eur Ann Allergy Clin Immunol ; 56(2): 51-64, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37462108

ABSTRACT

Summary: Anaphylaxis is a potentially fatal hypersensitivity reaction but frequently underrecognized. Although its incidence rates vary according to geographical location, it seems clear that there has been a general increase in recent years, either because of greater recognition of this entity or because it is progressing proportionally to the presence of allergic diseases in the world. The development of anaphylaxis management guidelines adapted to local or regional needs seems of utmost importance. Furthermore, it is necessary to assess their implementation and their positive effect regarding diagnosing and treating anaphylaxis. In this review we explore the currently existing definitions of anaphylaxis and its epidemiology, the potential triggers of anaphylaxis and guideline recommendations in terms of diagnosis and management, proposing a novel anaphylaxis calculator and reviewing the current scoring methods for anaphylactic episodes.


Subject(s)
Anaphylaxis , Humans , Anaphylaxis/diagnosis , Anaphylaxis/epidemiology , Anaphylaxis/therapy , Epinephrine , Incidence
18.
J Travel Med ; 31(2)2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38051650

ABSTRACT

BACKGROUND: The incidence of anaphylaxis after receipt of yellow fever (YF) vaccine is highly variable based upon previously published reports. Anaphylaxis after receiving the YF vaccine has been reported to range from 0 up to 22 per 1 000 000 doses. Our clinical experience suggested increased incidence, which prompted our investigation. We sought to evaluate the current incidence rate of anaphylaxis after receipt of the 17D-204 strain YF-VAX® brand reported in the US. METHODS: We performed a retrospective review of the Vaccine Adverse Event Reporting System (VAERS) reports of anaphylaxis after receiving the YF-VAX vaccine occurring between 1 October 1999 and 30 September 2018. We utilized the Brighton Collaboration Case Definition and inclusion determination was made by a board-certified allergist. We also obtained the total number of YF-VAX doses distributed across the US during this same time-period and then calculated an updated incidence rate of YF-VAX vaccine-associated anaphylaxis. RESULTS: We identified 132 potential cases of possible or probable anaphylaxis. Of these, 111 met inclusion criteria: level 1 (n = 51), level 2 (n = 59) and level 3 (n = 1). The manufacturer reported a total distribution of 7 624 160 doses of YF-VAX from 1 October 1999 to 30 September 2018. The calculated incidence rate of YF-VAX vaccine-associated anaphylaxis is estimated at 14.6 events per 1 000 000 doses. CONCLUSIONS: We conclude the estimated rate of anaphylaxis per VAERS reports is 14.6 events per 1 000 000 doses after YF-VAX vaccination. This is consistent with some previous reports and substantially higher than rates of anaphylaxis after other vaccines.


Subject(s)
Anaphylaxis , Yellow Fever Vaccine , Yellow Fever , Humans , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Incidence , Retrospective Studies , Vaccination/adverse effects , Yellow Fever/epidemiology , Yellow Fever/prevention & control , Yellow Fever Vaccine/adverse effects
19.
Int Arch Allergy Immunol ; 185(3): 228-236, 2024.
Article in English | MEDLINE | ID: mdl-38052182

ABSTRACT

INTRODUCTION: Venom immunotherapy (VIT) and adrenaline autoinjector (AAI) are important therapies in venom anaphylaxis. Adherence to VIT and AAI in patients with venom allergy has been evaluated in a few studies; however, solid data are lacking. This study aimed to evaluate VIT and AAI retrieval rates in patients with venom allergy with a special focus on adherence to treatment. Adherence was compared to subcutaneous immunotherapy (SCIT) with inhalant allergens. METHODS: This was a retrospective study among patients registered for allergen immunotherapy at the Allergy Center, Odense University Hospital, Denmark, from January 1, 2010, to December 31, 2014. Data on purchased immunotherapy and AAI were obtained from the Danish National Health Service Prescription Database. Multivariable logistic regression was used to analyze if allergen, age, sex, mastocytosis, and treatment site affected adherence. RESULTS: The 3-year adherence to VIT was 92.4% (244/264) compared to 87.4% (215/246) in SCIT with inhalant allergens, and the 5-year adherence to VIT was 84.1% (222/264) compared to 74.8% (184/246) in SCIT with inhalant allergens (p = 0.045). Females treated with VIT were more adherent than males (p = 0.45 [3-year], p = 0.008 [5-year]), whereas allergen, age, mastocytosis, or treatment site did not significantly affect adherence. Only 28.6% of patients (12/42) purchased an AAI after premature termination of VIT. CONCLUSION: In this register-based study, we found that the 3- and 5-year adherences to VIT and SCIT with inhalant allergens are at the upper end of the spectrum hitherto reported. Patients' 5-year adherence to VIT was higher than patients' 5-year adherence to SCIT with inhalant allergens. If VIT was prematurely terminated, less than 1/3 would have purchased an AAI.


Subject(s)
Anaphylaxis , Insect Bites and Stings , Mastocytosis , Venom Hypersensitivity , Male , Female , Humans , Epinephrine/therapeutic use , Retrospective Studies , State Medicine , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Desensitization, Immunologic/adverse effects , Allergens , Immunotherapy
20.
Ann Allergy Asthma Immunol ; 132(4): 512-518.e1, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38070650

ABSTRACT

BACKGROUND: Cow's milk is one of the most common and burdensome allergens in pediatrics, and it can induce severe anaphylactic reactions in children. However, data on cow's milk-induced anaphylaxis are sparse. OBJECTIVE: To describe the epidemiology of pediatric cow's milk-induced anaphylaxis and to determine risk factors for repeat emergency department (ED) epinephrine administration. METHODS: Between April 2011 and May 2023, data were collected on children with anaphylaxis presenting to 10 Canadian EDs. A standardized form documenting symptoms, triggers, treatment, and outcome was used. Multivariate logistic regression was used. RESULTS: Of 3118 anaphylactic reactions, 319 milk-induced anaphylaxis cases were identified (10%). In the prehospital setting, 54% of patients with milk-induced anaphylaxis received intramuscular epinephrine. In those with milk-induced anaphylaxis, receiving epinephrine before presenting to the ED was associated with a reduced risk of requiring 2 or more epinephrine doses in the ED (adjusted odds ratio, 0.95 [95% CI, 0.90-0.99]). Children younger than 5 years of age were more likely to experience a mild reaction compared with that in older children, who experienced a moderate reaction more often (P < .0001). Compared with other forms of food-induced anaphylaxis, children presenting with milk-induced anaphylaxis were younger; a greater proportion experienced wheezing and vomiting, and less experienced angioedema. CONCLUSION: Prehospital epinephrine in pediatric milk-induced anaphylaxis is underused; however, it may decrease risk of requiring 2 ED epinephrine doses. Milk-induced anaphylaxis in children younger than 5 years of age may be less severe than in older children. Wheezing and vomiting are more prevalent in milk-induced anaphylaxis compared with that of other foods.


Subject(s)
Anaphylaxis , Female , Animals , Cattle , Child , Humans , Anaphylaxis/drug therapy , Anaphylaxis/epidemiology , Anaphylaxis/etiology , Milk/adverse effects , Respiratory Sounds , Canada/epidemiology , Epinephrine/therapeutic use , Emergency Service, Hospital , Allergens , Vomiting/drug therapy
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