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Descriptive Analysis of Reported Adverse Events Associated with Vitiligo Medications Using FDA Adverse Event

Saleh F Alqifari1, Musaab Habibulla Gari2, Jeff J Guo2

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Summary
This summary is machine-generated.

This study assessed the safety of topical vitiligo treatments like Tacrolimus, Pimecrolimus, and Ruxolitinib. While local side effects were mild, systemic events like hospitalizations and pericarditis were noted, highlighting the need for ongoing safety monitoring.

Keywords:
FDA adverse event reporting system (FAERS)adverse eventscalcineurine inhibitorsruxolitinibvitiligo

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Area of Science:

  • Dermatology
  • Pharmacovigilance
  • Autoimmune Disorders

Background:

  • Vitiligo is an autoimmune condition causing skin depigmentation, with non-segmental vitiligo (NSV) previously managed off-label by calcineurin inhibitors.
  • The FDA approved Ruxolitinib cream in 2022 for NSV, targeting the JAK/STAT pathway.

Purpose of the Study:

  • To conduct a retrospective safety assessment of Tacrolimus, Pimecrolimus, and Ruxolitinib in vitiligo treatment.
  • To analyze adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.

Main Methods:

  • Retrospective descriptive analysis of FAERS data from 2013-2023.
  • Inclusion of patients aged 2 years and above, considering both brand and generic drug names.
  • Categorization of 844 adverse event reports (388 patients) into dermatological and systemic events.

Main Results:

  • Tacrolimus: 12 hospitalizations, 2 life-threatening events, 4 disabilities.
  • Pimecrolimus: Urticaria, pigmentation disorders, tooth fracture (primary systemic event).
  • Ruxolitinib: Predominant pericarditis, followed by anemia, headache, and urosepsis; mild local dermatological effects.

Conclusions:

  • Topical vitiligo treatments have varying systemic safety profiles.
  • Continuous post-marketing safety surveillance is crucial for topical vitiligo medications.
  • Vitiligo's psychological impact underscores the need for safe and effective treatments.