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

Author:

Zyryanov Sergey12ORCID,Asetskaya Irina1,Butranova Olga1ORCID,Terekhina Elizaveta1,Polivanov Vitaly3ORCID,Yudin Alexander24ORCID,Samsonova Kristina1

Affiliation:

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

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.

Publisher

MDPI AG

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