ArticleJournal of pharmaceutical health care and sciences2016
Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database.
Article in Journal of pharmaceutical health care and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers.
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48 citing papers in PubMed, 89 citations in OpenAlex.
- Integrating pharmacovigilance and machine learning: bleeding signal detection and risk prediction for oral anticoagulants in cancer patients.Research and practice in thrombosis and haemostasis · 2026Article
- Acetaminophen-induced Toxic Epidermal Necrolysis with Airway Mucosal Lesions.Internal medicine (Tokyo, Japan) · 2026Article
- Immunotherapy Safety in Thymic Epithelial Tumors: Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System.JMIR cancer · 2026Article
- Identifying New Candidate Predictors of Mortality in Japanese Patients with Severe Drug Eruptions.Drug safety · 2025Article
- Hypersensitivity Reactions to Anticonvulsants.Current allergy and asthma reports · 2025Review
- Article
- Vonoprazan-related adverse events: a pharmacovigilance study based on the FDA adverse event reporting system.Frontiers in medicine · 2025Article
- Disproportionality analysis of taste disorders using the FDA adverse event reporting system and Japanese adverse drug event report databases.Frontiers in pharmacology · 2025Article
- Emerging causes of anticancer therapies-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: evidence from disproportionality analysis of the FDA adverse event reporting system.Frontiers in immunology · 2025Article
- Adverse drug reactions to atezolizumab in combination with bevacizumab in hepatocellular carcinoma patients: an analysis of the food and drug administration adverse event reporting system database.Frontiers in pharmacology · 2025Article
- Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Adverse Event Profiles of the Third-Generation Aromatase Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS.Biomedicines · 2024Article
- Psychiatric disorders associated with PCSK9 inhibitors: A real-world, pharmacovigilance study.CNS neuroscience & therapeutics · 2024Article
- Evaluation of the Regulatory Required Post-Authorization Safety Study for Propacetamol: Nested Case-Control and Case-Time-Control Studies.Yonsei medical journal · 2024Article
- Association Between Antidiabetic Drugs and Delirium: A Study Based on the Adverse Drug Event Reporting Database in Japan.Clinical drug investigation · 2024Article
- Analysis of the risk of oncological adverse events associated with infliximab in combination with azathioprine compared to monotherapy: insights from the FAERS database.Frontiers in pharmacology · 2024Article
- Antihypertensive drug-associated adverse events in osteoarthritis: a study of a large real-world sample based on the FAERS database.Frontiers in pharmacology · 2024Article
- Stevens-Johnson Syndrome From Combined Allopurinol and Angiotensin-Converting Enzyme Inhibitors: A Narrative Review.Cureus · 2024Review
- Risk of delirium with antiepileptic drug use: a study based on the Japanese Adverse Drug Event Report database.International journal of clinical pharmacy · 2023Article
- Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system.CNS neuroscience & therapeutics · 2023Article
Corrections and comments
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Authors and funding
16 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions associated with fatal disorders. Although many causes of SJS/TEN have been proposed, the time-to-onset for SJS/TEN and the relationship between aging and SJS/TEN are still not clear. Therefore, the aim of this study was to determine the relationship between aging and SJS/TEN using the Japanese Adverse Drug Event Report (JADER) database and analyze the time-to-onset profile of SJS/TEN.
methodsWe analyzed reports of SJS/TEN recorded in the JADER database between 2004 and 2015 using an adjusted reporting odds ratio (ROR). We also used Weibull proportional hazards models for each drug to examine the expression patterns of SJS/TEN. We selected the drugs according to the number of the reports associated with SJS/TEN.
resultsThe JADER contained 330,686 reports from April 2004 to April 2015. The adjusted RORs for patients in the 0-19-, 20-39-, 60-79-, and ≥ 80-year-old groups from all data extracted from the JADER database were 1.33 (95 % confidence interval [CI], 1.21-1.45), 1.78 (95 % CI, 1.65-1.93), 0.71 (95 % CI, 0.66-0.75), and 0.72 (95 % CI, 0.66-0.79), respectively. The adjusted ROR tended to be higher in patients aged 0-19 years, particularly in patients using antipyretic analgesics, such as loxoprofen or acetaminophen. More than half of the cases of SJS/TEN onset following administration of loxoprofen and acetaminophen occurred within 4 days of the initiation of treatment. The median times-to-onset were 3 days for loxoprofen and 2 days for acetaminophen. The scale parameter α values of loxoprofen and acetaminophen were 9.44 and 6.17, respectively. The upper 95 % CIs of shape parameter β values for the drugs were all less than 1, with the exceptions of those for carbamazepine, ACE inhibitors, and corticosteroids.
conclusionsOur results suggested that monitoring of younger patients who frequently use antipyretic analgesics is important. These drugs should be used and monitored within the first 2-3 days of treatment in the Japanese population.
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