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

Yu, Roger; Krantz, Matthew S.; Phillips, Elizabeth; Stone, Cosby A.

doi:10.1016/j.jaip.2020.09.021

Cited by 86 publications

(78 citation statements)

References 36 publications

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“…The major limitation of this study is that the analysis is based on data mined from a voluntary SRS, and thus data are limited by under‐reporting of cases, indeterminate causality, and the potential existence of duplicate reports; 26 further, the definition and grading of anaphylaxis events recorded in the database are not well standardized or not enough accurate; therefore the data could only reflect some important trends in reports of anaphylaxis related to different mAbs, but could not be used to compare the incidence of anaphylaxis events among mAbs. Moreover, this data is mainly based on the US population, but prescription patterns or approval times of mAbs vary in different countries; therefore, the analysis conclusions could not be directly extrapolated to other countries.…”

Section: Discussionmentioning

confidence: 99%

Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab

Wang

Cui

et al. 2021

Clinical & Translational All

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Background Monoclonal antibodies (mAbs) are novel, effective therapeutics for the treatment of inadequately controlled severe asthma. Knowledge of the anaphylaxis risks related to different mAbs is essential for their appropriate and safe administration. This study aimed to evaluate the associations between different mAbs and anaphylactic reactions by applying statistical approaches to pharmacovigilance data. Methods This was a retrospective study using data from the US Food and Drug Administration Adverse Event Reporting System database from January 2004 to September 2020. A total of 2006 reports of anaphylaxis related to benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab were obtained through data mining. The clinical characteristics of the cases were analyzed, and the risk signals of anaphylactic reactions and corresponding outcomes were investigated in the five mAbs. Results The patients were mainly young and middle‐aged adults, with markedly more women than men. Omalizumab, benralizumab, reslizumab, and mepolizumab showed positive signals for anaphylaxis, while only dupilumab showed a negative signal. The risk of initial or prolonged hospitalization due to anaphylaxis was significantly higher in the benralizumab group than in the omalizumab group (42.86% vs. 28.92%, p = 0.024). Further, when anaphylaxis to omalizumab occurred, patients with asthma were more likely to have life‐threatening outcomes than those with chronic urticaria (18.0% vs. 12.9%, p = 0.022). Conclusion In the current real‐world study, the positive anaphylaxis signals related to omalizumab, benralizumab, reslizumab, and mepolizumab suggested the need for the close monitoring of patients after drug use, and dupilumab showed a negative signal for anaphylaxis.

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Section: Discussionmentioning

confidence: 99%

Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab

Wang

Cui

et al. 2021

Clinical & Translational All

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“…When we surveyed the suspected drugs besides anti-influenza drugs in each case, acetaminophen was the most common co-administered drug (21 cases), followed by levofloxacin (6 cases), cefcapene pivoxil hydrochloride (5 cases), and loxoprofen sodium (5 cases). Of these drugs, acetaminophen and levofloxacin were among the top 50 drugs associated with anaphylaxis in a survey using data from the FAERS database (6). Therefore, analysis considering the presence or absence of these drugs may be necessary in the future.…”

Section: Discussionmentioning

confidence: 99%

“…Drug-induced anaphylaxis is a well-known lifethreatening adverse effect associated with several drug classes (antimicrobials (especially beta-lactams), nonsteroidal anti-inflammatory drugs, opiates, and local anesthetics) (4,5). Recently, a study using data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database identified the top 50 drugs associated with reports of drug-induced anaphylaxis and drugs with more than 20 reported deaths following anaphylaxis (6). Although anti-influenza drugs were not included in this list, anti-influenza drug-induced anaphylaxis has been reported in clinical trials and postmarketing settings and the corresponding warning has been issued in package inserts.…”

Section: Introductionmentioning

confidence: 99%

Association between anaphylaxis and anti-influenza drug use: An analysis of the Japanese Adverse Drug Event Report database

Tanaka

Ohyama

Horikomi

et al. 2021

DD&T

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Anti-influenza drug, anaphylaxis, Japanese Adverse Drug Event Report database, laninamivir, peramivir, baloxavirWe aimed to investigate the association between anaphylaxis and anti-influenza drug use using the Japanese Adverse Drug Event Report (JADER) database, a national spontaneous reporting database in Japan. We surveyed registered cases from the JADER database between April 2004 and November 2019. The target drugs were five anti-influenza drugs, namely oseltamivir, zanamivir, peramivir, laninamivir, and baloxavir. Adverse events associated with anaphylaxis, "anaphylactic reaction," "anaphylactic shock," "anaphylactoid reaction," and "anaphylactoid shock," were evaluated. The association between anaphylaxis and anti-influenza drug use was assessed by calculating the reporting odds ratio (ROR) and information component (IC) as a measure of disproportionality. Signals were considered positive if the lower limit of the 95% confidence interval (CI) of ROR was > 1, and that of IC was > 0. The number of anaphylaxis cases associated with anti-influenza drug use was 199 (0.9%). Signals were detected for inhaled laninamivir (ROR: 4.24 [95%

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“…33 Shrimp, wheat, soybean, and rice are frequently reported to induce FDEIA, in which shrimp and wheat are most common. [34][35][36] In some cases of FDEIA, NSAIDs are a cofactor for enhancing anaphylaxis symptoms, especially in patients with wheat-induced FDEIA or plant foods (nuts, seeds, vegetables, and peanut)-derived lipid transfer proteins-induced FDEIA in the Mediterranean area. 37,38 In addition, anaphylactic events can be enhanced by other cofactors, such as temperature change, ingestion of vegetable or meat, food contaminated with aeroallergens (house dust mite and mold), and others (snail, taro, red bean, and mushroom).…”

Section: Food-induced Anaphylaxismentioning

confidence: 99%

Recent update on the management of anaphylaxis

et al. 2021

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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.

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

Cited by 86 publications

References 36 publications

Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab

Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab

Association between anaphylaxis and anti-influenza drug use: An analysis of the Japanese Adverse Drug Event Report database

Recent update on the management of anaphylaxis

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