Severe cutaneous adverse reactions due to antibiotics therapy: a pharmacovigilance analysis of FDA adverse event reporting system events

Zhou, Lu; Yang, Jing; Xiao, Min; Shan, HuiFang; Liu, MaoZhu; Lu, Yun; Zou, Ya; Wu, Bin

doi:10.1080/14740338.2023.2278685

Cited by 3 publications

(2 citation statements)

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“…β -Lactams, especially penicillins and cephalosporins, as well as sulfonamides, glycopeptides and quinolones were generally suspected to be the predominant triggers of SCARs ( 23 , 32 , 34 ), which was consistent with strong antibiotic-associated SCARs signals mined based on the FAERS database ( 35 ). Notably, there seems to be varying degrees of differences in the classes and proportion of the main culprit antibiotics in studies based on different regions.…”

Section: Discussionsupporting

confidence: 66%

Antibiotic-induced severe cutaneous adverse reactions: a single-center retrospective study over ten years

Lu,

Zhou,

Zou

et al. 2024

Front. Immunol.

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ObjectiveSevere cutaneous adverse reactions (SCARs) are rare but life-threatening, with antibiotics being the main cause. This retrospective study from a single center was designed to analyze the culprit drugs, clinical features and treatment outcomes of antibiotic-induced SCARs.MethodsWe analyzed cases of antibiotic-induced SCARs in a tertiary hospital in China between January 2013 and January 2024, including Steven-Johnson syndrome (SJS) or Stevens-Johnson syndrome-toxic epidermal necrolysis (SJS-TEN) overlap, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Descriptive analysis of the demographic characteristics, clinical manifestations, treatment and prognosis were carried out.ResultsAmong 354 cases of SCARs, 63 validated antibiotic-related cases were included. Cephalosporins (31.7%), penicillins (25.4%), and quinolones (19.0%) were the most common triggers for SCARs. Overall, liver (50.8%), lungs (31.7%), and kidneys (23.8%) were the most frequently affected organ in SCARs cases. Eight patients (28.6%) in the SJS/SJS-TEN overlap group and 8 patients (80.0%) in the TEN group received combination therapy of corticosteroids and IVIG. Patients with SCARs caused by penicillins or cephalosporins could receive alternative treatments such as lincomamides, quinolones, and tetracyclines. The mortality rate in the TEN group was the highest at 20.0%, followed by the SJS/SJS-TEN overlap group (7.1%), and no deaths were observed in the DRESS and AGEP groups.ConclusionThe identification of the culprit antibiotics and the application of alternative antibiotic therapies are crucial for the management of antibiotic-induced SCARs. If complicated underlying conditions and complications like advanced age, cancer and pneumonia coexist with SCARs, patients might be more at risk for mortality.

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Section: Discussionsupporting

confidence: 66%

Antibiotic-induced severe cutaneous adverse reactions: a single-center retrospective study over ten years

Lu,

Zhou,

Zou

et al. 2024

Front. Immunol.

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“…A newly published disproportionality analysis using the US Food and Drug Administration's Adverse Event Reporting System found that certain antibiotics such as sulfonamides, glycopeptides (eg, vancomycin), and penicillins carried a higher risk of serious cADRs than others. 33 However, this study lacked a control group, and pharmacovigilance databases are highly subject to reporting bias. In contrast, our study used population-based prescription records and a casecontrol design, circumventing the limitations inherent in disproportionality analyses.…”

Section: Discussionmentioning

confidence: 98%

Oral Antibiotics and Risk of Serious Cutaneous Adverse Drug Reactions

Lee,

Gomes,

Drucker

et al. 2024

JAMA

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ImportanceSerious cutaneous adverse drug reactions (cADRs) are potentially life-threatening drug hypersensitivity reactions involving the skin and internal organs. Antibiotics are a recognized cause of these reactions, but no studies have compared relative risks across antibiotic classes.ObjectivesTo explore the risk of serious cADRs associated with commonly prescribed oral antibiotics, and to characterize outcomes of patients hospitalized for them.Design, Setting, and ParticipantsNested case-control study using population-based linked administrative datasets among adults aged 66 years or older who received at least 1 oral antibiotic between 2002 and 2022 in Ontario, Canada. Cases were those who had an emergency department (ED) visit or hospitalization for serious cADRs within 60 days of the prescription, and each case was matched with up to 4 controls who did not.ExposureVarious classes of oral antibiotics.Main Outcomes and MeasuresConditional logistic regression estimate of the association between different classes of oral antibiotics and serious cADRs, using macrolides as the reference group.ResultsDuring the 20-year study period, we identified 21 758 older adults (median age, 75 years; 64.1% female) who had an ED visit or hospitalization for serious cADRs following antibiotic therapy and 87 025 matched controls who did not. In the primary analysis, sulfonamide antibiotics (adjusted odds ratio [aOR], 2.9; 95% CI, 2.7-3.1) and cephalosporins (aOR, 2.6; 95% CI, 2.5-2.8) were most strongly associated with serious cADRs relative to macrolides. Additional associations were evident with nitrofurantoin (aOR, 2.2; 95% CI, 2.1-2.4), penicillins (aOR, 1.4; 95% CI, 1.3-1.5), and fluoroquinolones (aOR, 1.3; 95% CI, 1.2-1.4). The crude rate of ED visits or hospitalization for cADRs was highest for cephalosporins (4.92 per 1000 prescriptions; 95% CI, 4.86-4.99) and sulfonamide antibiotics (3.22 per 1000 prescriptions; 95% CI, 3.15-3.28). Among the 2852 case patients hospitalized for cADRs, the median length of stay was 6 days (IQR, 3-13 days), 9.6% required transfer to a critical care unit, and 5.3% died in the hospital.Conclusion and RelevanceCommonly prescribed oral antibiotics are associated with an increased risk of serious cADRs compared with macrolides, with sulfonamides and cephalosporins carrying the highest risk. Prescribers should preferentially use lower-risk antibiotics when clinically appropriate.

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Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

Sandes,

Figueras,

Lima

2024

Antibiotics

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The spread of antimicrobial resistance (AMR) is a global challenge. Close and continuous surveillance for quick detection of AMR can be difficult, especially in remote places. This narrative review focuses on the contributions of pharmacovigilance (PV) as an auxiliary tool for identifying and monitoring the ineffectiveness, resistance, and inappropriate use of antibiotics (ABs). The terms “drug ineffective”, “therapeutic failure”, “drug resistance”, “pathogen resistance”, and “multidrug resistance” were found in PV databases and dictionaries, denoting ineffectiveness. These terms cover a range of problems that should be better investigated because they are useful in warning about possible causes of AMR. “Medication errors”, especially those related to dose and indication, and “Off-label use” are highlighted in the literature, suggesting inappropriate use of ABs. Hence, the included studies show that the terms of interest related to AMR and use are not only present but frequent in PV surveillance programs. This review illustrates the feasibility of using PV as a complementary tool for antimicrobial stewardship activities, especially in scenarios where other resources are scarce.

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Severe cutaneous adverse reactions due to antibiotics therapy: a pharmacovigilance analysis of FDA adverse event reporting system events

Cited by 3 publications

References 33 publications

Antibiotic-induced severe cutaneous adverse reactions: a single-center retrospective study over ten years

Antibiotic-induced severe cutaneous adverse reactions: a single-center retrospective study over ten years

Oral Antibiotics and Risk of Serious Cutaneous Adverse Drug Reactions

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

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