Drug-associated porphyria: a pharmacovigilance study.

Area of Science:

• Pharmacovigilance
• Drug Safety
• Metabolic Disorders

Background:

• Porphyria attacks, potentially fatal, are triggered by porphyrinogenic drugs.
• Assessing drug safety for porphyria carriers is a significant clinical challenge.

Purpose of the Study:

• To identify drugs associated with porphyria using a large adverse event database.
• To provide critical information on drug porphyrogenicity for clinical decision-making.

Main Methods:

• Retrospective analysis of the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) data (2004-2022).
• Utilized four signal mining algorithms to detect associations between drugs and porphyria adverse events.
• Screened 406 drugs using specific search terms related to porphyria.

Main Results:

• 1470 cases of porphyria-related adverse events were reported in FAERS.
• 52 drugs were identified with significant signals of association with porphyria across all four algorithms.
• Detailed analysis of the characteristics of reported cases and identified drugs was performed.

Conclusions:

• This study is the first to report drug-associated porphyria using comprehensive data analysis.
• Findings facilitate rational, evidence-based drug prescription and improve porphyrogenicity prediction.
• Provides a crucial reference for clinicians to avoid prescribing porphyrinogenic drugs to porphyria mutation carriers.