Is acetaminophen associated with a risk of Stevens–Johnson syndrome and toxic epidermal necrolysis? Analysis of the French Pharmacovigilance Database

Lebrun‐Vignes, Bénédicte; Guy, Claire; Jean-Pastor, M. J.; Gras‐Champel, Valérie; Zénut, M.

doi:10.1111/bcp.13445

Cited by 28 publications

(26 citation statements)

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“…epidermal necrolysis) was manually written in the certificate of death by the practitioner in charge of the patient, so the diagnosis is probably more reliable. Likewise, false‐positive cases in the FPVD and RegiSCAR databases are estimated to be low . Secondly, the capture–recapture method has other limitations .…”

Section: Discussionmentioning

confidence: 99%

“…Likewise, false-positive cases in the FPVD and RegiSCAR databases are estimated to be low. 25 Secondly, the capture-recapture method has other limitations. [15][16][17] The possible dependence between sources was controlled by including interaction terms into the models, but this might not be adaptable to small capture samples and may have led to a lack of precision in the estimated interaction coefficient and in turn may have affected the estimates.…”

Section: Discussionmentioning

confidence: 99%

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Incidence of and mortality from epidermal necrolysis (Stevens–Johnson syndrome/toxic epidermal necrolysis) in France during 2003–16: a four‐source capture–recapture estimate

et al. 2019

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Summary Background Because of its rarity, the exact incidence of and mortality from epidermal necrolysis (Stevens–Johnson syndrome/toxic epidermal necrolysis) is difficult to establish and closely depends on the size and type of the data source. Objectives To estimate the incidence of and mortality due to epidermal necrolysis in France over a 14‐year period. Methods Data from four national databases were analysed. A capture–recapture analysis was performed. Results A total of 2635 incident cases of epidermal necrolysis were recorded in at least one of the four databases during the study period [males: 47·9%; median age: 52 (interquartile range 25–72) years]. On capture–recapture analysis, the estimated total number of cases was 5686, for an overall estimated annual incidence of 6·5 (95% confidence interval 4·1–8·9) cases per million inhabitants. The estimated annual incidence rates were 4·1 (0·3–7·9) cases per million inhabitants < 20 years of age, 3·9 (1·5–6·3) cases per million inhabitants aged 20–64 years and 13·7 (5·4–22·0) cases per million inhabitants ≥ 65 years of age. The estimated overall annual mortality rate from epidermal necrolysis was 0·9 (0·1–1·8) case per million inhabitants. It was 0·6 (0·1–1·5) case per million inhabitants aged 20–64 years and 2·8 (0·9–6·6) cases per million inhabitants ≥ 65 years of age (deaths in people < 20 years old were too rare to provide an accurate estimate). Conclusions The annual incidence of epidermal necrolysis is higher than the one to five cases per million inhabitants usually reported. Such estimations could be helpful in establishing appropriate healthcare plans for people with epidermal necrolysis, in particular the need for specialized care units. What's already known about this topic? Few data are available regarding incidence of and mortality from epidermal necrolysis in the general population. Experts in epidermal necrolysis have recently proposed an annual incidence of one to five cases per million individuals. The overall mortality rate is usually reported to be between 10% and 20%. What does this study add? Using a four‐source capture–recapture method and data from a 14‐year period (2003–16), the annual incidence of and mortality from epidermal necrolysis were estimated to be 6·5 (95% confidence interval 4·1–8·9) and 0·9 (0·1–1·8) cases per million French inhabitants, respectively. Such estimations could be helpful in establishing appropriate healthcare plans, in particular the need for specialized care units.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Incidence of and mortality from epidermal necrolysis (Stevens–Johnson syndrome/toxic epidermal necrolysis) in France during 2003–16: a four‐source capture–recapture estimate

et al. 2019

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“…Studies regarding the association between medications treated for a dental diseases and SJS are scarce. 10,16,17 Owing to the presence of a mild cutaneous lesion, the patient in this study was diagnosed with atypical SJS, according to the study by Lebrun-Vignes et al 4…”

Section: Discussionmentioning

confidence: 99%

“…2 The difference between SJS, SJS/TEN overlap, and TEN is defined by the percentage of epidermal detachment with respect to body surface area distinguishes: SJS is defined as skin involvement of <10%; TEN is defined as skin involvement of >30%; and SJS/TEN overlap as 10%-30% skin involvement, resulting in increasing severity and a worsening prognosis of the disease as the percentage of skin involvement increases. 3,4 Drugs, such as anti-epileptic drugs, antibiotics, pain killers/antipyretics, and/or bacterial infections, such as Mycoplasma pneumoniae, and viral, such as herpes virus infections have been widely known to cause SJS. 2,[5][6][7][8] Till date, many marketed drugs are known to cause SJS.…”

Section: Introductionmentioning

confidence: 99%

Acetaminophen‐induced atypical Stevens‐Johnson syndrome in a patient with acute oral bacterial infection: A case report and literature review

Goto

Yamashiro

Maruyama

et al. 2020

Oral Science International

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Stevens‐Johnson syndrome (SJS) is a rare but fatal disease and is characterized by various clinical symptoms, including acute inflammatory vesiculobullous lesion of skin, oral cavity, ocular surface, genitals, etc Drugs, such as anti‐epileptic drugs, antibiotics, pain killers/antipyretics, and/or bacterial infections have been widely known to cause SJS. Herein, we report a 40‐year‐old man with atypical SJS caused by acetaminophen, which was used for treating an acute odontogenic infection. The patient presented with several risk factors associated with SJS; thus, careful monitoring of the patient's drug history is mandatory to treat acute inflammation in the oral cavity.

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“…In this case, as the use of amoxicillin has been associated with SJS , the use of this product may be a confounding factor in the analysis of the causal relationship between calcium carbimide and SJS. In relation to paracetamol, on the other hand, one recently-published study by Lebrun-Vignes (2017) suggested that there is no evidence for a causal relationship between the use of paracetamol and the occurrence of SJS and TEN.…”

Section: Discussionmentioning

confidence: 99%

Risk factors for, and treatment of, Stevens-Johnson syndrome and toxic epidermal necrolysis: Evidence from the literature

Silva¹,

Novaes²,

GÃ¶ttems³

et al. 2018

Afr. J. Pharm. Pharmacol.

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Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are adverse drug reactions.They occur in the form of mild and sometimes severe cutaneous eruptions, with high morbidity and mortality, requiring fast and appropriate diagnosis and treatment. The aim of this study was to describe and discuss the evidence regarding the risk factors, complications and treatment of SJS and TEN in inpatients. The present study is a literature review of case reports published between January 1981 and December 2016, in the following databases: The Virtual Health Library (Biblioteca Virtual da Saúde -BVS), MEDLINE (National Library of Medicine, USA), LILACS (Latin American and Caribbean Health Sciences Literature), and PUBMED -NCBI (National Center for Biotechnology Information). A total of thirteen case reports were selected. Most of the cases (54%) developed adverse reactions to anticonvulsant drugs. The most common were valproic acid, lamotrigine and carbamazepine. In 69% of all cases, the patients were female. The patients' age range varied from 18 to 82 years old. In two cases which correspond to 15%, the patients were either infected with HIV or were receiving chemotherapy treatment for cancer. These patients had a higher possibility for immunosuppression. In relation to the actions taken as treatment, the suspension of the drugs or the treatment of the skin lesions occurred in 85 and 54% of the cases, respectively. A total of 6 cases, corresponding to 46%, occurred in the Latin American and Caribbean region. In conclusion, the use of anticonvulsants, and female gender, are among the main risk factors identified by the study. The main therapeutic action for SJS and TEN is the suspension of the use of the drug that triggered the inflammatory process and the topical treatment of the lesions caused.

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Is acetaminophen associated with a risk of Stevens–Johnson syndrome and toxic epidermal necrolysis? Analysis of the French Pharmacovigilance Database

Abstract: After analysis of the French pharmacovigilance data using the ALDEN algorithm, we found no obvious SJS/TEN risk related to the use of acetaminophen in this large national series.

Cited by 28 publications

References 32 publications

Incidence of and mortality from epidermal necrolysis (Stevens–Johnson syndrome/toxic epidermal necrolysis) in France during 2003–16: a four‐source capture–recapture estimate

Incidence of and mortality from epidermal necrolysis (Stevens–Johnson syndrome/toxic epidermal necrolysis) in France during 2003–16: a four‐source capture–recapture estimate

Acetaminophen‐induced atypical Stevens‐Johnson syndrome in a patient with acute oral bacterial infection: A case report and literature review

Risk factors for, and treatment of, Stevens-Johnson syndrome and toxic epidermal necrolysis: Evidence from the literature

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