Severe cutaneous adverse reactions associated with systemic ivermectin: A pharmacovigilance analysis

Abstract

Despite poor evidence, the antiparasitic ivermectin has been advocated as a potential COVID‐19 therapy. This has led to a rise in calls to poison‐control centers by people self‐medicating with ivermectin, which is sold over the counter for veterinary uses. We aimed to investigate the association between severe cutaneous adverse reactions (SCARs) and ivermectin. Postmarketing data from the FDA Adverse Event Reporting System (FAERS), gathered between 2014 and 2021, was employed to detect disproportional signals of SCARs following systemic ivermectin therapy. The reporting odds ratio (ROR) was used to quantify the strength of association, while adjusting for age, sex, and region. The search yielded 517 reports of systemic ivermectin (median age 54 years, 46.8% female), of which 25 (4.8%), 81 (15.7%), and 411 (79.5%) were classified as SCARs, nonsevere cutaneous adverse events (AEs), or noncutaneous AEs, respectively. The regional distribution differed between SCAR reports (32.0% from Africa and 12.0% from North America) compared with other AEs, which originated from North America in over half of cases. The most common SCARs were toxic epidermal necrolysis (seven cases), Stevens–Johnson syndrome (seven cases), and drug reaction with eosinophilia and systemic symptoms (four cases). Five SCAR cases (20.0%) resulted in death and 12 (48.0%) lead to hospitalization. There was a strong safety signal for any SCAR (adjusted ROR 3.34, 95% confidence interval [CI] 2.17–5.12) and toxidermias (adjusted ROR 7.08, 95% CI 4.23–11.84). This study suggests that ivermectin is associated with SCARs on rare occasions. Dermatologists should be aware of this given the increase in ivermectin misuse.

Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database

“…For the aforementioned reason, in this study, we introduced the pharmacovigilance method as a more uniform metric for risk assessments to evaluate the ADR signals of each drug at the SMQ and PT levels. Although there have been studies using signal mining methods to assess the risk of drugs causing SCARs, the scope of the research is limited to specific drug classes or SCAR subclasses (Xu et al, 2021;Zhu et al, 2021;Bomze et al, 2022), so that the risk comparison between drugs can only be achieved within a limited range. In this study, we extended this scope to all reported culprit-drugs to date, allowing for cross-drug class, cross-PT risk Frontiers in Pharmacology frontiersin.org assessment (Supplementary Table S1), which is more applicable to rapidly assess the risk of drugs causing SCARs in clinical practice.…”

Id reaction following the treatment of a cutaneous larva migrans

“…A drug eruption to ivermectin cannot be excluded; however, cutaneous adverse reactions associated with systemic ivermectin are rare. 6 , 7 , 8 , 9 A drug eruption would not be limited to both hands and feet but would involve the whole body. Id reaction was suspected because hands and feet skin manifestations were associated with the plantar inflammatory CLM after treatment.…”

Medication Associations With Severe Cutaneous Adverse Reactions: A Case/Non-Case Analysis Using the FDA Adverse Event Reporting System

“…Prior case-control studies in Europe (EuroSCAR) and smaller studies exploring the association of individual medications have been performed to establish the classically implicated medications in SCARs. [8][9][10][11][12][13][14][15][16][17] However, a comprehensive analysis of medications with association with SJS, TEN, DRESS, and AGEP using data from The United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) has not been completed. The goal of this study is to examine all 4 categories of SCARs using FAERS and provide an updated and stratified list of medications with significant reporting odds ratios (RORs).…”