Nonsteroidal anti-inflammatory drugs were the most frequent triggers of drug-induced anaphylaxis in Latín America, whereas antibiotics elicited faster onset and more scvere reactions. An improvement was observed in epinephrinc use and adherence to guidelines in the emergency department treatment of anaphylaxis in Latín America compared with our last report.Facultad de Ciencias Médica

Alcaraz Duarte, Perla

Arias Cruz, Alfredo

Bernstein, Jonathan A.

Calderón, Juan Carlos

Canamar, David Eugenio Roman

Castillo, Antonio J.

Cherrez Ojeda, Iván

Cuello, Mabel Noemi

De Barayazarra, Susana

D’Onofrio Silva, Ana Carolina

Ensina, Luis Felipe

Falco, Alicia de

Fernandoz Ramíre Zuluaga, Luis

Giavina Bianchi, Pedro

González Díaz, Sandra Nora

Guerzet Ayres Bastos, Patricia

Gómez, Maximiliano

Jaller, Rodolfo

Jares, Edgardo

Juan Pineda, Ángeles

Macías Weinmann, Alejandra

Mancilla Ávila, Octavio

Monge, Patricia

Monsell, Silvana

Monteiro, Luciane

Morelo Rocha Felix, Mara

Morfín Maciel, Blanca

Piraino, Pedro

Rangel Gonzalez, Diana María

Santoyo Grandados, Illian

Serrano Reyes, Carlos

Serrano, Roberto Gustavo

Solé, Dirceu

Sánchez Borges, Mario

Villa, Ricardo Cardona

Vinuesa, Miguel

Weisz, Adriana

Zanacchi, Viviana Andrea

The Journal of Allergy and Clinical Immunology In Practice

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ARTICLE IN PRESSClinical CommunicationsDrug-induced anaphylaxis, elicitors, risk factors, and management in Latín AmericaEdgardo José Jares, MDa, Ricardo Cardona Villa, MDb, Mario Sánchez-Borges, MDC, Alicia de Falco, PhDa, Luis Felipe Ensina, PhD0, Jonathan A. Bernstein, MD1, Alfredo Arias-Cruz, MD9, Ivan Cherrez-Ojeda, MD, MSch, Blanca Morfín Maciel, MD1,Alejandra Macías-Weinmann, MD1,Sandra González Díaz, MD', Dirceu Solé, PhD",Pedro Giavina Bianchi, MD1, Susana de Barayazarra, MD"', Mabel Cuello, MD", Miguel Vinuesa, MD°,Juan Carlos Calderón, MDP, Viviana A. Zanacchi, MD"’, Silvana Monsell, MDa, Mara Morelo Rocha Félix, PhD9, Carlos Serrano Reyes, MD', Pedro Piraino, MDS, Rodolfo Jaller, MD', Patricia Guerzet Ayres Bastos, MD", and Maximiliano Gómez, MD, PhDu; On behalf of "Latín America Drug Allergy Interest Group"Clinical Implications• Nonsteroidal anti-inflammatory drugs were the most frequent triggers of drug-induced anaphylaxis in Latín America, whereas antibiotics elicited faster onset and more scvere reactions. An improvement was observed in epinephrinc use and adherence to guidelines in the emergency department treatment of anaphylaxis in Latín America compared with our last report.TO THE EDITOR:Drugs are among the most frequent elicitors of anaphylaxis, especially in adults and hospitalized patients.1 Although studies from France and Portugal found that beta-lactam antibiotics were the most frequent drug-induced anaphylaxis (DIA) elici­tors,2’' the main drugs claimed as triggers of DIA in Latín America (LA) are nonsteroidal anti-inflammatory drugs (NSAIDs).'1 The aim of this study was, using a drug anaphylaxis—specific questionnaire, to provide new data on the clinical presentation, risk factors. and acute treatment of DIA in LA.An Online survey modified from the European NetWork of Drug Allergy questionnaire was used to obtain patient demographic data and the clinical features, severity, and chro- nology of anaphylactic reactions5 (severity grading system and causality definitions in Tables El and E2 in this article’s Online Repository at www.jaci-inpractice.org) to implicated drugs over 2 years. In addition, acure management of the DIAs adminis- tered to patients was obtaincd. The results included all the patients with DIA reponed to the registry between January 2017 and November 2018 by 22 allergy units from 8 LA countries. A total of 286 DIA cases were reponed. The main demographic data are summarized in Table I.Mild, moderare, severe, and fatal reactions were present in 4.20%, 59.44%, 36.01%, and 0.35% of patients, respectively. Children/adolescents, adults (18-59 years oíd), and elderly pa­tients (>60 years oíd) experienced severe reactions in 12%, 37.17%, and 57.78% of cases, respectively (children/adolescents vs adults: P < .001; adults vs elderly: P < .05). In the unadjusted logistic regression, a 10-fold increase (odds ratio, 10.03; 95% CI, 3.55-28.33) and a 4-fold increase (odds ratio, 4.44; 95% CI. 1.80-10.93) in the chance for a severe reaction was found in elderly and adults, respectively, compared with children- adolescents. Older age has been recognized previously as a risk factor for more severe anaphylaxis.No significant difference in severity was found between patients with or without an allergic history (severe reactions 31.4% vs 40.3%, P = .093), or an asthma history (severe reactions: 30.8% vs 37.6%; P = .354).Previous reaction with the implicated drug, or a drug from the same group, was present in 24.5% of patients (milder reactions, 18.6%; similar or more severe reaction 5 9%). These DIA reactions emphasizc the importance of educating physicians about taking a careful history regarding previous drug-induced hypersensitivity reactions.Oral (68.2%) and intravenous (IV) (22%) were the most common routes associated with DIAs. The IV route induced severe reactions in 48.3% of patients compared with 31.3% for the oral route (P < .05). In addition, drugs administered via the IV route induced quicker onset of reactions; 55.2% versus 20.6% during the first 10 minutes for the IV and oral routes, respectively (P < .00001). This is in accordance with other studies where patients receiving parenterallv administered drugs presented more severe and faster reactions.2'4,7The main inducers causing certain/probable DIA were NSAIDs (54.6%), beta-lactam antibiotics (16.6%), and non- —beta-lactam antibiotics (6.4%). The predominan! reactions to NSAIDS might be related to the fact that these drugs are easily obtained over the counter in most LA countries and self- medication especially with NSAIDs is very common in this región. Ibuprofen (24.3%) and metamizole (21.7%) were the most frcquently implicated NSAIDs in the entire population, whereas diclofenac was the most prevalent NSAID in the elderly group (40.74%), possibly linked to their higher use for osteo- arthritis. Antibiotics more frequently induced severe reactions (beta-lactams 43.4% and non—beta-lactams 44.4%) compared with NSAIDs (27.7%) (P < .05). Beta-lactam antibiotic reactions occurred during the 10-minute period after drug intake in 42.3% of cases compared with NSAID reactions, which occurred in 19 9% of cases during the same time period (P < .005). These findings might be explained by differences in the involved mechanisms. Beta-lactam—induced DIA are believed to be IgE-mediated reactions that can result in systemic reactions including vascular instability, whereas NSAID DIA are believed to be primarily related to imbalance of prostaglandins/ leukotrienes production due to cyclooxygenase blocking that typically manifest as cutancous and respiratory reactions.8Most patients received glucocorticoids (80.1%) and antihis- tamines (80.4%). Epinephrine was administrated in 49.6% of cases, intramuscularly 41.6% and subcutaneously 8% of cases1ARTICLE IN PRESS2 CLINICAL COMMUNICATIONS J ALLERGY CLIN IMMUNOl PRACT MONTH 2019TABLE I. Demographic data of all questionnaire responderosCharacteristicOverall Children-adolescents (0-17 y)(n = 50)Adults (18-83 y)(n = 236) P valué adults/children-adolescents(N = 286)N 286 50 236Age (y), median 37 (24-52) 11.0 (8-14) 41.0 (31-56) C.0011Sex, %Male 35.7 58.0 30.9 <.000*Fentale 64.3 42.0 69.1Allergic background, % 47.9 66.0 44.1 <.005*Rhinitis, % 36.7 52.0 33.5 <■014*Aslhma, % 18.2 36 14.4 <.000*Food allergy, % 6.3 8.0 5.9 NSAtopic dermatitis, % 4.9 12.0 3.4 <.010*Hymenoptera venom allergy, % 3.8 14.0 1.7 <.000*Látex allergy % 1.7 2.0 1.7 NSPrevious drug reactions, % 32.5 26.0 33.9 NSFamily history of allergy. % 28.7 48.0 24.6 <.007*/VS', Nonsignificanl.•P < .05. X2-tP < .05. Mann-Whitney U test.Plasma ExpandersOxigenSC EpinephrineIM EpinephrineAntihistaminesCorticosteroids60102011-2014 2017-2018FIGURE 1. (A) Acute treatment of anaphylaxis. (B) Change in epinephrine use in Latin America from 2011-2014 (Jares et ald) to 2017-2018. SC, Subcutaneous; IM, intramuscular.ARTICLE IN PRESSJ ALLERGY CLIN IMMUNOL PRACT VOLUME ■ NUMBER ■CLINICAL COMMUNICATIONS 3(Figure 1, A). Intramuscular epinephrine is the cornerstone of anaphylaxis treatment,9 but its use has remained low in different parts of the world. In a previous study on DIA in LA, we found that epinephrine was used only in 27.6% of cases.4 (Figure 1, fí). We speculate that the use of epinephrine in these situations is improving with continued cducation and awareness. Glucocor- ticoids are used in most of the patients with DIA, in spite of the lack of evidence supporting its effectiveness.Biphasic anaphylaxis was prescnt in 11 patients (3.84%). Severe reactions were present in 45.45% of patients with biphasic and 36% with nonbiphasic anaphylaxis (P= .53, nonsignificant). The biphasic group received epinephrine in 27.27% of cases and sys- tcmic glucocorticoids in 90.90% of cases during the carly phasc response. This is in contrast to the nonbiphasic group that received epinephrine in 50.91% (P = .14, nonsignificant) of cases and systemic glucocorticoids in 80% (P = .41, nonsignificant) of cases. Although not significant, this trend for reduced biphasic reactions in those patients treated with epinephrine early on is consisten! with reports suggesting that epinephrine is more effective than systemic glucocorticoids at preventing biphasic reactions.10This study has a number of strengths because it is a large DIA population from LA using a validated questionnaire survey. Furthermore, clinical evaluations were performed in Allergy Units, permitting a more accurate trigger diagnosis.However, limitations inelude lack of generalizability because patients were from Allergy Units, and their management may not refiect care provided in General Medicine Units. Furthermore, this was a retrospective descriptive questionnaire study that has inherent reporting bias.In summary, this study found that NSAIDs were the most frequent triggers of DIA in LA, whereas antibiotics elicited faster onset and more severe reactions. Epinephrine was used in almost half the patients with DIA, mostly by the intramuscular route, demonstrating improved adherence to guidelines in the ED treatment of anaphylaxis since our last survey.'"Nuevo Hospital San Roque. Córdoba, Argentina"Hospital Pediátrico, Córdoba, Argentina“Universidad de Rosario, Rosario. ArgentinapRespiralab. Guayaquil. EcuadorqFederal Hospital of Servidores do Estado, Rio De Janeiro, Brazil'Fundación Valle del Lili. Cali, Colombia"Instituto de Previsión Social-Hospital Central, Asunción, Paraguay'Centro de Asma. Alergia c Inmunología Rodolfo Jaller, Barranquilla. Colombia "Fundación Ayrc, Salla, ArgentinaConflicts of interese The authors declare that they have no relevanl conflicts of interest.Rcccivcd for publicalion May 5. 2019; revisad October 6, 2019; acccptcd for publicalion October 7, 2019.Availablc onlinc ■ ■Corrcsponding aulhor: Edgardo José Jares, MD, Av Rivadavia 14276, Ramos Mejía,Provincia de Buenos Aires, Argentina. E-mail: cdgardojares@gmail.com. 2213-2198© 2019 American Academy of Allergy, Asthma & Immunology https://doi.org/ i 0.1016/j.jaip.2019.10.002*L1BRA Foundation, Buenos Aires, ArgentinaUniversidad de Antioquia, Mcdcllín, Colombia'Centro Medico-Docente La Trinidad. Caracas, Venezuela‘‘Universidad Nacional de La Plata. La Plata. Argentina'Federal University of Sao Paulo. Sao Paulo, Brazil'University of Cincinnati, Cincinnati. Ohio^Universidad Autónoma de Nuevo León, Monterrey, MéxicohUniversidad Espíritu Santo. Guayaquil. Ecuador'Hospital San Angel, México, México'Universidad Autónoma de Nuevo León, Monterrey, MéxicokFcderal University of S3o Paulo, Escola Paulista de Medicina. S3o Paulo, Brazil University of Sao Paulo. Sao Paulo, BrazilREFERENCES1. Gonzalez-Estrada A, Silvers SK, Klein A. Zell K. Wang XF, Lang DM. Epidcmiology of anaphylaxis al a tertiary care ccntcr: a report of 730 cases. Ann Allergy Asthma Immunol 2017;118:80-5.2. Renaudin JM. Beaudouin E, Ponvert C, Demoly P, Moneret-Vautrin DA. Se­vere drug-induccd anaphylaxis.analysis of 333 cases recordcd by the Allergy Vigilance NetWork from 2002 to 2010. Allergy 2013;68:929-37.3. Ribeiro-Vaz 1, Marques J, Demoly P. Polónia J, Gomes ER. Drug-induced anaphylaxis: a decade review of reporting to the Ponuguese Pharmacovigilance Authority. Eur J Clin Pharmacol 2013;69:673-81.4. Jares El. Baena-Cagnani CE, Sánchez-Borges M. Ensina LF. Arias-Cruz A. Gómez M. et al. Drug-induced anaphylaxis in Latin American countries. J Allergy Clin Immunol Pract 2015;3:780-8.5. Sampson HA, Munoz-Furlong A, Campbell RL. Adkinson NF Jr. Bock SA. Branum A, et al. Second symposium on the deíinition and management oí anaphylaxis: summary report: second National Institute of Allergy and lnfec- tious Discase/Food Allergy and Anaphylaxis NetWork symposium. J Allergy Clin Immunol 2006; 117:391-7.6. Sundquist B. José J. Pauze D. Pauze D. Wang H. Jarvinen KM. Anaphylaxis risk factors for hospitalization and intensive care: a comparison between adults and children in an upstatc New York cmcrgcncy department. Allergy Asthma Proc 2019;40:41-7.7. Gabrielli S. Clarke AE, Eisman H, Morris J. Joseph L, La Vieille S, el al Disparilics in rale, triggers, and management in pcdiatric and adult cases of suspected drug-induced anaphylaxis in Cañada. Imnnin Inflanim Dis 2()I8;6: 3-12.8. Dona I, Barrionucvo E, Salas L. Laguna JJ. Agúndcz J, Garcia-Martín E, ct al. NSAIDs-hypersensitivity often induces a blended reaction pattern involving múltiple organs. Sci Rep 2018:8:16710.9. Murare A. Roberts G. Worm M, Biló MB, Brockow K, Fernández Rivas M, et al. Anaphylaxis: guidelines from the European Academy of Allergy and Clinical Immunology. Allergy 2014;69:1026-45.10. Lee S. Peterson A, Lohse CM, Hess EP. Campbell RL. Further evaluation of factors that may predict biphasic reactions in cmcrgcncy department anaphy­laxis patients. J Allergy Clin Immunol Pract 2017;5:1295-301.ARTICLE IN PRESS3,e1 CLINICAL COMMUNICATIONS J ALLERGY CLIN immunol practMONTH 2019ONLINE REPOSITORY referencesEl. Brown SG. Clinical fealures and severity grading of anaphylaxis. J Allergy Clin Immunol 2004;114:371-6.E2. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD índex.F 2019. Available from: httpsy/www,whocc.no/a1c_ddd_index/. AccessedTABLEE1. Severity criteria______________________________ janUary 2, 2019SEVERE (hypoxia, hypotension, or neurologic compromise) Cyanosis orSpO2 < 92% at any stage, hypotension (systolic blood pressure < 90mnt Hg in adults), confusión, collapse, loss of consciousness. orincontinenceMODERATE (fealures suggesting respiratory, cardiovascular, orgastrointestinal involvement) Dyspnca, stridor, wheezc, nausea,vomiting, dizziness (presyncope), diaphoresis, chest or throat tightness,or abdominal painMILD (skin and subcutaneous tissues only) including generalizederythema, urticaria, periorbital edema, or angioedemaTABLE E2. Causality criteria62CERTAIN• Event or laboratory test abnormality, with plausible time relationship to drug intake• Cannot be cxplained by disease or other drugs• Response to withdrawal plausible (pharmacologically, pathologically)• Event delinitive pharmacologically or phenomenologically (ie, an objective and specific medical disorder or a recognized pharmacological phenomenon)• Rechallengc satisfactory, if necessary PROBABLE/LIKELY• Event or laboratory test abnormality. with reasonable lime relationship to drug intake• Unlikely to be attributed to disease or other drugs• Response to withdrawal clinically reasonable• Rechallenge nol requiredPOSSIBLE• Event or laboralory test abnormality. with reasonable time relationshipto drug intake• Could also be explained by disease or other drugs• Information on drug withdrawal may be lacking or unclear UNLIKELY• Event or laboratory test abnormality. with a time to drug intake that makes a relationship improbable (bul not impossible)• Disease or other drugs provide plausible explanalions CONDITIONAL/Unclassified• Event or laboratory test abnormality• More data for proper assessment needed, or• Additional data under examinationUNASSESSABLE/UNCLASSIFIABLE: Report suggesting an adverse reaction• Cannot be judged bccausc information is insufficicnt or contradictor* • Data cannot be supplemented or verified

Drug-induced anaphylaxis, elicitors, risk factors, and management in Latin America

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Drug-induced anaphylaxis, elicitors, risk factors, and management in Latin America

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