Drug-induced Anaphylaxis Research Articles

ANALYSIS OF DRUG-INDUCED ANAPHYLAXIS CASES USING THE JAPANESE ADVERSE DRUG EVENT REPORT DATABASE

The epidemiology of drug-induced anaphylaxis (AN) using the Japanese nationwide database has not been reported, even though drugs are a common trigger of AN. This study aimed to describe the epidemiological profile of drug-induced AN, including fatal cases, using the Japanese Adverse Drug Event Report database (JADER). We extracted data regarding drug-induced adverse events between April 2004 and February 2018 published in JADER by the Pharmaceuticals and Medical Devices Agency. We analyzed cases of anaphylaxis occurring between January 2005 and December 2017. The drug classification was based on the Japanese Standard Commodity Classification. There were 16916 cases of anaphylaxis reported during the study period. Among them, 418 fatalities were registered. The incidence of drug-induced AN and fatal cases was 1.03 cases/year per 100000 population and 0.03 cases/year, respectively. The most frequent causes of AN were diagnostic agents including X-ray contrast media (20.3%) and biological agents including human blood preparations (20.1%). In fatal cases, diagnostic agents (28.7%) and antibiotics (23.9%) were the most frequent causes. The frequency of drug-induced AN and fatalities in Japan remained unchanged over the 12-year period analyzed in this study. Diagnostic and biological agents were the most frequent causes of AN. Contrarily, fatalities were most frequently caused by diagnostic and antibiotic agents.

Clinical features of anaphylaxis in children.

Background: Despite the considerable increase in anaphylaxis frequency, there are limited studies on clinical features of anaphylaxis in children in developing countries. Objective: We aimed to analyze the demographic and clinical features of anaphylaxis in children in Turkey by comparing different age groups and triggers. Methods: Medical records of 147 children, ages 0-18 years, diagnosed with anaphylaxis between 2010 and 2019 were retrospectively analyzed. Results: The mean ± standard deviation age at first anaphylaxis episode was 5.9 ± 5.2 years, with a male predominance (63.9%); 25.2% were infants and 52.4% were < 6 years of age at their first anaphylaxis episode; 78.2% were atopic, with the highest frequency in children with food-induced anaphylaxis (FIA). The home (51.7%) was the most frequent setting. The overall leading cause of anaphylaxis was food (44.2%), which was more frequent at < 6 years of age, followed by drugs (28.6%) and bee venom (22.4%), both were more frequent among older children (>6 years). The patients with venom allergy had the highest rate of rapid onset of symptoms (p < 0.001). Gastrointestinal symptoms were observed significantly more in infants (48.6%) and in children with FIA (38.5%); cardiovascular symptoms were more frequently observed in children > 6 years of age (48.6%) and in children with drug-induced anaphylaxis (64.3%). Although recurrent anaphylaxis was reported for 23.1% of the patients, it was highest in the patients with FIA (35.9%). Overall, only 47.6% of the patients received epinephrine in the emergency department (ED) and 27.3% were referred to an allergy specialist, with the patients with FIA having the lowest rate for both, 32.3% and 10.8%, respectively. Children with drug-induced anaphylaxis had the highest rate of severe anaphylaxis (57.1%). Conclusion: There is a need to improve anaphylaxis recognition and management in all children regardless of age and trigger. Inadequate treatment was most evident in infants and patients with FIA.

Causes and Diagnostic Usefulness of Tryptase Measurements for Anaphylaxis in a Korean Tertiary Care General Hospital.

The causes of anaphylaxis in a general hospital may differ from those occurring in a community setting. Underlying diseases in admitted patients and vague presenting symptoms can make the diagnosis of anaphylaxis difficult. Serum tryptase measurements may provide valuable evidence for diagnosing anaphylaxis in admitted patients. This study was designed as a retrospective study of 53 patients with an anaphylaxis episode at a Korean tertiary care general hospital. Tryptase levels were measured at baseline and different time points from the onset of anaphylaxis. Drugs (42 cases; 79.2%) and foods (10 cases; 18.9%) were the most common causes of anaphylaxis. In drug-induced anaphylaxis, antibiotics (24.5%), anticancer medications, which included monoclonal antibodies (22.6%), and contrast agents (11.3%) were the most frequent causes. The muscle relaxant eperisone (5.7%), neuromuscular blocking agent rocuronium (5.7%), and its antagonist sugammadex (3.8%) were other frequent triggering agents. Wheat-dependent exercise-induced anaphylaxis was the most common entity in food-induced anaphylaxis. Tryptase concentrations were higher in patients with higher grades of anaphylaxis, as well as in accidental anaphylaxis, compared to meticulously provoked anaphylaxis. Overall diagnostic sensitivity was higher for tryptase algorithm criteria (≥[1.2×baseline+2] µg/L: 71.4%) than for abnormal tryptase level criteria (≥11.4 µg/L: 52.8%). The triggers of anaphylaxis in a Korean tertiary care hospital were diverse, including beta-lactam antibiotics, anticancer medications, contrast medias, eperisone, nonsteroidal anti-inflammatory drugs, rocuronium, sugammadex, and wheat. Tryptase measurements provided valuable evidence for diagnosis, and the sensitivity of algorithm criteria was superior to that of the abnormal value criteria.

Anaphylaxie aux antalgiques, antipyrétiques et anti-inflammatoires non stéroïdiens : analyse des cas déclarés au Réseau d’Allergo-Vigilance de 2002 à 2020

Non-opioid analgesics, antipyretics and non-steroidal anti-inflammatory drugs are the second cause of drug hypersensitivity and a major cause of drug-induced anaphylaxis. In this retrospective study, we analyzed epidemiological, demographic and clinical characteristics of the cases of anaphylaxis induced by these drugs and collected by the French Allergy-Vigilance Network (RAV) from 2002 to 2020 and compared our results with those of Pharmacovigilance, French and international data. One hundred and fourteen cases were collected. This number is very low, as compared with the French Pharmacovigilance data (1498), due to a low number of allergists who reported these cases to the RAV. Although the documentation of cases was not homogeneous (patient's medical history, risk factors, allergological work-up), our results are nearly similar to those of the French and international data. They confirm that these drugs are the second cause of drug-induced anaphylaxis, often secondary to self-medication with paracetamol and ibuprofen. They also confirm that hypersensitivity to these drugs is more frequent in adults than in children, that a personal atopy is a risk factor for allergic hypersensitivity, and that anaphylactic reactions are undertreated (underuse of epinephrine). They also suggest that reactions due to allergic hypersensitivity are more frequent in children than in adults. Finally, our results confirm that the diagnostic value of skin tests, specific IgE determinations and basophil activation tests is low, and that diagnosis of HS to these drugs is mainly based on a suggestive clinical history and/or provocation tests.

Antibody or Anybody? Considering the Role of MRGPRX2 in Acute Drug-Induced Anaphylaxis and as a Therapeutic Target.

Acute anaphylaxis to small molecule drugs is largely considered to be antibody-mediated with immunogloblin E (IgE) and mast cell activation being key. More recently, a role for drug-reactive immunoglobulin G (IgG) with neutrophil activation has also been suggested, at least in reactions to neuromuscular blocking agents (NMBAs). However, the mast cell receptor MRGPRX2 has also been highlighted as a possible triggering mechanism in acute anaphylaxis to many clinically used drugs. Significantly, MRGPRX2 activation is not dependent upon the presence of drug-recognising antibody. Given the reasonable assumption that MRGPRX2 is expressed in all individuals, the corollary of this is that in theory, anybody could respond detrimentally to triggering drugs (recently suggested to be around 20% of a drug-like compound library). But this clearly is not the case, as the incidence of acute drug-induced anaphylaxis is very low. In this mini-review we consider antibody-dependent and -independent mechanisms of mast cell activation by small molecule drugs with a focus on the MRGPRX2 pathway. Moreover, as a juxtaposition to these adverse drug actions, we consider how increased understanding of the role of MRGPRX2 in anaphylaxis is important for future drug development and can complement exploration of this receptor as a drug target in broader clinical settings.

Hypersensitivity reactions to chemotherapy: an EAACI Position Paper.

Chemotherapeutic drugs have been widely used in the treatment of cancer disease for about 70years. The development of new treatments has not hindered their use, and oncologists still prescribe them routinely, alone or in combination with other antineoplastic agents. However, all chemotherapeutic agents can induce hypersensitivity reactions (HSRs), with different incidences depending on the culprit drug. These reactions are the third leading cause of fatal drug-induced anaphylaxis in the United States. In Europe, deaths related to chemotherapy have also been reported. In particular, most reactions are caused by platinum compounds, taxanes, epipodophyllotoxins and asparaginase. Despite their prevalence and relevance, the ideal pathways for diagnosis, treatment and prevention of these reactions are still unclear, and practice remains considerably heterogeneous with vast differences from center to center. Thus, the European Network on Drug Allergy and Drug Allergy Interest Group of the European Academy of Allergy and Clinical Immunology organized a task force to provide data and recommendations regarding the allergological work-up in this field of drug hypersensitivity reactions. This position paper aims to provide consensus on the investigation of HSRs to chemotherapeutic drugs and give practical recommendations for clinicians that treat these patients, such as oncologists, allergologists and internists. Key sections cover risk factors, pathogenesis, symptoms, the role of skin tests, in vitro tests, indications and contraindications of drug provocation tests and desensitization of neoplastic patients with allergic reactions to chemotherapeutic drugs. Statements, recommendations and unmet needs were discussed and proposed at the end of each section.

Recent update on the management of anaphylaxis.

Anaphylaxis is a life-threatening systemic allergic reaction presenting various clinical manifestations. Its prevalence has increased in almost all age groups and both sexes. Food, venom, and drugs are major causes in both children and adults; a higher prevalence of food-induced anaphylaxis is noted in children, while a higher prevalence of drug-induced anaphylaxis is noted in adults. The pathogenic mechanism is mediated by immunologic and nonimmunologic mechanisms, where mast cells and basophils are key cells that release mediators. A diagnosis of anaphylaxis is mainly based on clinical symptoms and physical findings; however, an increased serum tryptase level is a useful biomarker. Epinephrine is the first-line drug to treat acute symptoms, and an epinephrine auto-injector should be prescribed for each patient. Antihistamines and systemic corticosteroids are used to relieve symptoms. This review updates current issues in the management of anaphylaxis as well as the new guidelines for proper diagnosis and treatment.

Anaphylaxis and epinephrine autoinjector use in pediatric patients with cutaneous mastocytosis.

Mastocytosis is a complex disorder presenting with a broad clinical spectrum. In this study, we aimed to evaluate the frequency of systemic symptoms, necessity of the usage of epinephrine autoinjectors (EAI), and factors affecting the use of EAI among pediatric patients with cutaneous mastocytosis (CM). The study population was composed of 53 patients with CM. The clinical data were collected from the medical files. A questionnaire about the patient's anaphylaxis experiences and treatment attitudes toward EAI was performed. Thirty-three of 53 patients were male (62.3%), and the median age of the study participants was 80months. Anaphylaxis was reported in two patients (3.7%). One of the patients had drug-induced anaphylaxis, and the other had venom-induced anaphylaxis. Three patients (5.6%) reported a personal history of EAI use due to systemic symptoms. Patients with higher serum tryptase level and cases of familial mastocytosis had more systemic symptoms (P=.012 and P=.010, respectively). The patient rate of compliance with EAI for prescription filling and carrying the EAI was 88.7% and 79.2% respectively. 41.5% of parents were hesitant to use EAI when necessary, although they were trained for the use of it by medical staff. The rate of anaphylaxis in patients with CM in the current study wassignificant and justifies prescribing EAI. Detailed education and counseling on EAI usage are needed to reduce parental hesitancy.

Risk factors of beta-lactam anaphylaxis in Korea: A 6-year multicenter retrospective adult case-control study

BackgroundBeta-lactams (BLs) are commonly used antibiotics and leading causative agents of drug-induced anaphylaxis. Few studies on the culprit drugs and risk factors of BL-induced anaphylaxis are available. Our goal was to evaluate the culprit drugs and compare the risk factors in patients with BL-induced anaphylaxis to matched tolerant controls in a hospital setting. MethodsWe retrospectively enrolled all patients who developed anaphylaxis from intravenous BL during hospitalization from 9 Korean hospitals. We compared clinical parameters between patients with BL-induced anaphylaxis and 4-fold BL-tolerant controls matched by age, sex, BL use, and the purpose of BL administration. ResultsSeventy-four cases of BL-induced anaphylaxis and 296 BL-tolerant controls were enrolled. Cephalosporin accounted for 77% of total BL-induced anaphylaxis, and the top derivatives were ceftriaxone (23.0%), cefazedone (10.8%), and cefbuperazone (9.5%). Among penicillin derivatives, piperacillin (16.2%) was the most common, followed by ampicillin (2.7%). History of drug allergy (odds ratio [OR], 19.91; 95% confidence interval [CI] 5.33–74.44), previous exposure to the causative BL (OR, 7.71; 95% CI, 1.62–36.76), and concurrent administration of angiotensin-converting enzyme inhibitors (ACEIs) (OR, 5.97; 95% CI, 1.28–27.91) were independent risk factors associated with BL-induced anaphylaxis. Food allergy (OR, 13.93; 95% CI 1.31–148.9) and previous exposure to BL (OR, 6.59; 95% CI, 1.30–33.31) were identified as risk factors for cephalosporin-induced anaphylaxis. ConclusionsTo prevent BL-induced anaphylaxis, attention should be paid to histories of drug or food allergy, previous exposure to BLs, and ACEI use. The risk factors and clinical outcomes might vary according to the BL classes.

Comprehensive hospital-based regional survey of anaphylaxis in Japanese children: Time trends of triggers and adrenaline use

BackgroundSince few studies have analyzed time trends in pediatric anaphylaxis, including triggers and adrenaline usage, this study aimed to reveal these issues in a comprehensive analysis of pediatric anaphylaxis cases. MethodsThe Aichi Medical Association performed a comprehensive survey of pediatric anaphylaxis cases aged under 15 years from 87 secondary and 25 tertiary emergency care hospitals in Aichi Prefecture (population 7.5 million), Japan. ResultsBetween April 2016 and March 2020, 3423 cases of anaphylaxis were identified. Food items were the most frequent trigger (73%), followed by exercise after food ingestion (4.3%), and drugs (2.2%). Egg (19%) and milk (17%) specifically were the most frequent among food triggers, while the largest proportional increase was observed in tree nuts from 6.0% in 2017 to 15% in 2019. Overall, 1647 (48%) cases were admitted to the hospital, of which 26 (0.8%) were admitted to the intensive care unit. Drug-induced anaphylaxis was associated with the highest admission rate (71%). Of the 2493 food-induced anaphylaxis cases, 1107 (44%) were treated with adrenaline. Among them, 343 cases included previously prescribed adrenaline auto-injectors (AAI), with 225 (66%) usages prior to hospital arrival. There was no significant difference in the admission rate between the cases in which AAIs were used and those with adrenaline administered in the hospital (68% and 72%, respectively). ConclusionsThe proportion of tree nuts in food-induced anaphylaxis increased significantly. Although prehospital AAI use has become widespread, it was not associated with lower admission rate compared to in-hospital adrenaline usage.

Drug-induced anaphylaxis: most frequently caused by NSAIDs

Drug-induced anaphylaxis: most frequently caused by NSAIDs

Revisiting the role of MRGPRX2 on hypersensitivity reactions to neuromuscular blocking drugs.

Anaphylaxis is caused by a variety of triggers including Food and Drug Administration (FDA)-approved antibiotics, contrast media and neuromuscular blocking drugs (NMBDs). Traditionally, drug-induced anaphylaxis was thought to result mainly from IgE-mediated histamine release from mast cells. Recently, a G protein-coupled receptor known as MRGPRX2 has been identified and shown to be highly expressed on human skin but not lung mast cells. The demonstration that many NMBDs induce degranulation in human mast cells via MRGPRX2 led to the idea that this receptor contributes to NMBD-induced hypersensitivity reactions. However, other studies have raised doubts regarding its role in drug-induced hypersensitivity. This review discusses the current status and controversy on MRGPRX2's role on NMBD-induced hypersensitivity.

Anaphylaxis Induced by Intravenous Tacrolimus Administration During Kidney Transplant Surgery: A Case Report

A 35-year-old male patient with end-stage renal disease due to vesicoureteral reflux preemptively received a renal graft from his father. The patient had a history of allergy to contrast-enhancing media. He received oral tacrolimus (TAC) and mycophenolate mofetil without any problems for 2 days before kidney transplantation. During the induction period of the surgery, his systolic blood pressure (sBP) decreased to 60 mmHg approximately 1 hour after initiating intravenous tacrolimus (TAC-IV) and intravenous piperacillin (PIPC), and the anesthesiologist suspected drug-induced anaphylaxis and stopped administration of the medications. Because TAC had been administered preoperatively without any adverse events, PIPC was suspected as the causative agent of the anaphylaxis. After the patient's hemodynamics returned to baseline, TAC-IV was restarted. However, his sBP rapidly decreased to 40 mmHg and the patient developed wheezing. He was diagnosed with drug-induced anaphylaxis due to castor oil derivatives in the TAC-IV formulation. The patient's sBP was restored with the administration of some vasopressors, and kidney transplantation was then performed without difficulty. Two days after kidney transplantation, oral TAC was administered without anaphylaxis. Clinicians should consider that not only the drug itself but also its additives or metabolites could induce anaphylaxis.

Drug-induced anaphylaxis in the emergency department: A prospective observational study.

Objective:Anaphylaxis is an acute, life-threatening, systemic hypersensitivity reaction. It is usually triggered by drugs, foods, and insect stings. The primary objective of our study is to determine the factors affecting drug-induced anaphylaxis to contribute to early diagnosis and treatment in these patients.Methods:Patients over 18 years old who were diagnosed drug-induced anaphylaxis in the Goztepe Hospital within a period of 1 year were evaluated prospectively. Patients demographical data, etiological factors, clinical findings, and treatment information were recorded.Results:Forty-four patients were enrolled in the study of which 25 (56.8%) were female. The median age of women and men was 54 (min: 22, max 82) and 44 (min 18, max 82), respectively. Twenty-three (52%) of them had a history of anaphylaxis. The most common causes of drug-induced anaphylaxis were antibiotics (36%) and nonsteroidal anti-inflammatory drugs (18%), respectively. Adrenaline was applied to 17 (38%) of the patients in the treatment.Conclusion:Antibiotics were the most common drugs causing drug-induced anaphylaxis and adrenaline was underused which is the first-line treatment in the anaphylaxis. Some clinicians refrain from administering adrenaline. The reasons underlying this approach should be investigated.

Emerging Causes of Drug-Induced Anaphylaxis: A Review of Anaphylaxis-Associated Reports in the FDA Adverse Event Reporting System (FAERS)

Drug-induced anaphylaxis is a well-known adverse drug reaction for some drug classes, but emerging drug causes of anaphylaxis and novel mechanisms may contribute in unrecognized ways. We sought to determine the top drugs reported in association with anaphylaxis and anaphylaxis followed by death in the Food and Drug Administration Adverse Event Reporting System (FAERS). We reviewed the publicly available FAERS database from 1999 to 2019. Using search terms "anaphylactic shock" or "anaphylactic reaction" and sorting cases by generic drug names, we counted and trended reports to FAERS in which a drug was associated with anaphylaxis or anaphylaxis followed by death. From 1999 to 2019, there were 17,506,002 adverse drug events reported in FAERS, of which 47,496 (0.27%) were reported as anaphylaxis. Excluding patients without age, sex, or country data, respectively, the median age of patients in reports of anaphylaxis was 52 (interquartile range: 28), 62.71% were female, and 13,899 of 34,381 (40.43%) reports were from the United States. There were 2984 of 47,496 (6.28%) reports of anaphylaxis followed by death. Top drug classes associated with anaphylaxis in FAERS were antibiotics, monoclonal antibodies (mAbs), nonsteroidal anti-inflammatory drugs, and acetaminophen. Top drug classes associated with anaphylaxis deaths were antibiotics, radiocontrast agents, and intraoperative agents. Linear regression demonstrated reports of anaphylaxis to mAbs increasing at an average rate of 0.77% of total anaphylaxis reports per year (95% confidence interval: 0.65, 0.88) from 2.00% in 1999 to 17.37% in 2019, faster than any other drug class. Antibiotics were highly reported for anaphylaxis overall and anaphylaxis followed by death. Increasing reports were noted for anaphylaxis to mAb therapies.

Drug-induced anaphylaxis and drug sales: Why the discordance?

Drug-induced anaphylaxis and drug sales: Why the discordance?

P1856KIDNEY CRISES: USING IN SITU SIMULATION TEACHING TO FACILITATE MULTIDISCIPLINARY TEAM WORKING IN RENAL EMERGENCIES

Abstract Background and Aims The haemodialysis unit is a unique clinical environment. Specialist nursing staff look after patients, frequently without on-site medical cover, and need to manage medical issues until help arrives. Junior doctors often have limited experience managing renal patients and may not be aware of specialty-specific issues when dealing with medical emergencies. The different skill sets in these groups creates an opportunity for shared learning. Simulation teaching provides a safe environment for individuals to develop communication, team working and clinical skills and helps facilitate discussion and reflection on clinical scenarios. We describe a programme of renal in situ simulation sessions for nurses and junior doctors to allow them to practise their roles in an emergency and evaluate feedback on their perception of the programme. Method Seventeen hour-long simulation sessions were delivered between June 2017 and January 2020 within the renal ward in 2 hospitals and in a satellite outpatient dialysis unit. They utilised a high-fidelity SimMan® mannequin. Scenarios were based on common or rare-but-serious medical emergencies (hyperkalaemic cardiac arrest, arrhythmia on dialysis, air embolism, major haemorrhage post-renal biopsy, line sepsis, hypertensive seizure, pulmonary oedema and drug-induced anaphylaxis). Sessions comprised an orientation to the mannequin, a clinical scenario and a debrief discussion. Doctors and nurses completed post-tutorial feedback exploring their thoughts on the programme. Results 59 healthcare professionals (40 doctors and 19 nurses) participated and completed post-event feedback. All attendees felt that sessions improved their knowledge and increased their confidence in managing similar scenarios in the future. They all felt they would be able to apply their learning to their day job. 86% of participants strongly agreed that the programme helped them develop stronger relationships with colleagues. In white-space boxes, individuals described the sessions as being helpful in developing communication, teamwork, leadership and delegation skills in addition to specific learning points for the individual scenarios. Sessions also identified practical issues, such as where to source medications or monitoring equipment, and led to the creation of an updated protocol folder and distribution of Advanced Life Support algorithms throughout the ward. Conclusion Nurses and junior doctors report increased confidence in managing medical emergencies in renal patients and improved relationships with colleagues following a simulation training programme. The programme promotes a learning culture within the unit. It provides an opportunity to discuss potentially serious situations and allows reflection on similar scenarios encountered within the ward and dialysis unit. Further work is needed to determine if in situ simulation teaching has an impact on patient outcome measures.

A Case of Lymphangioleiomyomatosis with Bronchospasm and Pulmonary Hypertension Correlated with Drug-induced Anaphylaxis during General Anesthesia

A Case of Lymphangioleiomyomatosis with Bronchospasm and Pulmonary Hypertension Correlated with Drug-induced Anaphylaxis during General Anesthesia

Drug-induced anaphylaxis: prevalence, risk factors, triggers

Currently, there is a tendency to increase the prevalence of drug-induced anaphylaxis. Medicines occupy a leading position among the causes of the development of anaphylactic reactions in the adult group of patients and second place in children, the most significant in this matter are non-steroidal anti-inflammatory drugs, antibacterial drugs and X-ray contrast agents. The risk of developing of drug anaphylaxis in most cases is not predictable, while the frequency of severe and fatal reactions is extremely high. This article presents an analysis of current data regarding the prevalence, possible risk factors, and triggers of drug anaphylaxis.

Analysis of individual case safety reports of drug-induced anaphylaxis to the Korea Adverse Event Reporting System

Purpose: To identify causative agents of the drug-induced anaphylaxis (DIA) by using the Korea Institute of Drug Safety & Risk Man agement-Korea Adverse Event Reporting System (KIDS-KAERS) database (Ministry of Food and Drug Safety) in Korea and to check their labeling information regarding anaphylaxis. Methods: Among Individual Case Safety Reports from January, 2008 to December 2017, cases of DIA were analyzed for demo graphics, causative agents and fatal cases resulting in death. The domestic drug labeling, Micromedex and U.S. Food and Drug Ad ministration (FDA) drug package insert, were reviewed to check if the labeling information on suspected causative agents contains anaphylaxis. Results: A total of 4,700 cases of DIA were analyzed. The mean age was 49.85±18.32 years, and 2,642 patients (56.2%) were females. Among 8,664 drugs reported as causative agents, antibiotics (27.4%) accounted for the largest portion. There were 18 fatal cases: antibiotics (7 cases), antineoplastic agents (4 cases) were the major causative drugs for the mortality cases. Of 513 drugs reported as suspected causative agents, 103 (20.1%) did not list anaphylaxis as an adverse effect on domestic drug labeling and 16 (3.1%) did not reflect anaphylaxis in any of 3 adverse drug information. Conclusion: Analysis of 10-year data showed that antibiotics were the main cause of DIA and the mortality rate was 0.7%. In 3.1% of suspected drugs, there was no description of anaphylaxis in any of the drug labeling. (Allergy Asthma Respir Dis 2020;8:30-35)