Stevens–Johnson Syndrome and Toxic Epidermal Necrolysis: Analysis of the Russian Database of Spontaneous Reports

(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.

Авторы
Zyryanov Sergey1, 2 , Asetskaya Irina 1 , Butranova Olga 1 , Terekhina Elizaveta 1 , Polivanov Vitaly3 , Yudin Alexander2, 4 , Samsonova Kristina 1
Журнал
Издательство
MDPI AG
Номер выпуска
6
Язык
Английский
Страницы
675
Статус
Опубликовано
Том
17
Год
2024
Организации
  • 1 Department of General and Clinical Pharmacology, Peoples’ Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia
  • 2 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
  • 3 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
  • 4 Russian National Research Medical University Named after N.I. Pirogov, St. Ostrovityanova, 1, 117997 Moscow, Russia
Дата создания
11.09.2024
Дата изменения
11.09.2024
Постоянная ссылка
https://repository.rudn.ru/ru/records/article/record/157501/
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