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Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Analysis of the Russian Database of Spontaneous Reports.
Zyryanov, Sergey; Asetskaya, Irina; Butranova, Olga; Terekhina, Elizaveta; Polivanov, Vitaly; Yudin, Alexander; Samsonova, Kristina.
Afiliación
  • Zyryanov S; Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia.
  • Asetskaya I; Moscow City Health Department, City Clinical Hospital No. 24, State Budgetary Institution of Healthcare of the City of Moscow, Pistzovaya Str. 10, 127015 Moscow, Russia.
  • Butranova O; Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia.
  • Terekhina E; Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia.
  • Polivanov V; Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia.
  • Yudin A; Pharmacovigilance Center, Information and Methodological Center for Expert Evaluation, Record and Analysis of Circulation of Medical Products under the Federal Service for Surveillance in Healthcare, 4-1 Slavyanskaya Square, 109074 Moscow, Russia.
  • Samsonova K; Moscow City Health Department, City Clinical Hospital No. 24, State Budgetary Institution of Healthcare of the City of Moscow, Pistzovaya Str. 10, 127015 Moscow, Russia.
Pharmaceuticals (Basel) ; 17(6)2024 May 24.
Article en En | MEDLINE | ID: mdl-38931343
ABSTRACT
(1)

Background:

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are extremely severe cutaneous adverse drug reactions which are relatively rare in routine clinical practice. An analysis of a national pharmacovigilance database may be the most effective method of obtaining information on SJS and TEN. (2)

Methods:

Design-a retrospective descriptive pharmacoepidemiologic study of spontaneous reports (SRs) with data on SJS and TEN retrieved from the Russian National Pharmacovigilance database for the period from 1 April 2019 to 31 December 2023. Descriptive statistics was used to assess the demographic data of patients and the structure of suspected drugs. (3)

Results:

A total of 170 SRs on SJS and TEN were identified, of which 32.9% were SJS and 67.1%-TEN. In total, 30% were pediatric SRs, 21.2%-SRs of the elderly. There were 12 lethal cases, and all cases were TEN. The leading culprit drugs were anti-infectives for systemic use and nervous system agents. The top 10 involved drugs are as follows lamotrigine (23.5%), ibuprofen (12.9%), ceftriaxone (8.8%), amoxicillin and amoxicillin with beta-lactam inhibitors (8.8%), paracetamol (7.6%), carbamazepine (5.9%), azithromycin (4.1%), valproic acid (4.1%), omeprazole (3.5%), and levetiracetam (3.5%). (4)

Conclusions:

Our study was the first study in Russia aimed at the assessment of the structure of the drugs involved in SJS and TEN on the national level.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pharmaceuticals (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Rusia Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pharmaceuticals (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Rusia Pais de publicación: Suiza