Many Drugs Associated With SJS-TEN in Children, WHO Data Analysis Show

TOPLINE:

Antiepileptic and anti-infectious agents were the most common drugs associated with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) in children in an analysis of a World Health Organization (WHO) database.

METHODOLOGY:

• SJS and TEN are rare, life-threatening mucocutaneous reactions mainly associated with medications, but large pharmacovigilance studies of drugs associated with SJS-TEN in the pediatric population are still lacking.
• Using the WHO's pharmacovigilance database (VigiBase) containing individual case safety reports from January 1967 to July 2022, researchers identified 7342 adverse drug reaction reports of SJS-TEN in children (younger than 18 years; median age, 9 years) in all six continents. Median onset was 5 days, and 3.2% were fatal.
• They analyzed drugs reported as suspected treatments, and for each molecule, they performed a case–non-case study to assess a potential pharmacovigilance signal by computing the information component (IC).
• A positive IC value suggested more frequent reporting of a specific drug-adverse reaction pair. A positive IC₀₂₅, a traditional threshold for statistical signal detection, is suggestive of a potential pharmacovigilance signal.

TAKEAWAY:

• Overall, 165 drugs were associated with a diagnosis of SJS-TEN; antiepileptic and anti-infectious drugs were the most common drug classes represented.
• The five most frequently reported drugs were carbamazepine (11.7%), lamotrigine (10.6%), sulfamethoxazole-trimethoprim (9%), acetaminophen (8.4%), and phenytoin (6.6%). The five drugs with the highest IC₀₂₅ were lamotrigine, carbamazepine, phenobarbital, phenytoin, and nimesulide.
• All antiepileptics, many antibiotic families, dapsone, antiretroviral drugs, some antifungal drugs, and nonsteroidal anti-inflammatory drugs were identified in reports, with penicillins the most frequently reported antibiotic family and sulfonamides having the strongest pharmacovigilance signal.
• Vaccines were not associated with significant signals.

IN PRACTICE:

The study provides an update on "the spectrum of drugs potentially associated with SJS-TEN in the pediatric population," the authors concluded, and "underlines the importance of reporting to pharmacovigilance the suspicion of this severe side effect of drugs with the most precise and detailed clinical description possible."

SOURCE:

The study, led by Pauline Bataille, MD, of the Department of Pediatric Dermatology, Hôpital Necker-Enfants Malades Hospital, Paris City University, Paris, France, was published online in the Journal of the European Academy of Dermatology and Venereology.

LIMITATIONS:

Limitations include the possibility that some cases could have had an infectious or idiopathic cause not related to a drug and the lack of detailed clinical data in the database.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflict of interest.