Dysbiosis Reactions in Pharmacovigilance: A Focused Study Using FDA FAERS Database

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Bayram Özgür D., Akıcı A.

II. Eurasia International Congress of Health Sciences, Baku, Azerbaycan, 1 - 02 Ocak 2025, ss.85, (Özet Bildiri)

  • Yayın Türü: Bildiri / Özet Bildiri
  • Basıldığı Şehir: Baku
  • Basıldığı Ülke: Azerbaycan
  • Sayfa Sayıları: ss.85
  • Acıbadem Mehmet Ali Aydınlar Üniversitesi Adresli: Evet

Özet

Introduction: Dysbiosis, an imbalance in the gut microbiota, has been increasingly recognized as a potential adverse reaction of various pharmacotherapies. Adverse event (AE) databases, such as the FDA Adverse Event Reporting System (FAERS), provide valuable data for identifying and analyzing patterns of reactions associated with specific drugs. This study aims to analyze dysbiosis-related AEs reported in the FDA FAERS database.

Method: All 813 dysbiosis cases reported in the FAERS database (2006–2024) were analyzed, focusing on gender, age group, and reaction severity. Drugs mentioned in these reports were categorized using ATC codes.

Results: Of the 813 dysbiosis cases analyzed, 46.5% of the patients were women, while 10.3% did not specify their gender. The majority of cases (47.5%) occurred in individuals aged 18–64 years. Serious events accounted for 88.1% of all reported cases. Dysbiosis was the sole reported reaction in 74 cases (9.1%). Among the 813 reports, 358 (44.0%) involved a single suspected active ingredient. The most frequently reported drugs were ciprofloxacin (13.0%), levofloxacin (12.0%), and meropenem (11.9%). When analyzing the ATC codes of drugs with a single active ingredient, the top five were: J01M (quinolone antibacterials, 12.6%), J01D (other beta-lactam antibacterials, 12.5%), L04A (immunosuppressants, 11.0%), J01X (other antibacterials, 10.2%), and J01F (macrolides, lincosamides, and streptogramins, 4.1%).

Conclusion: These findings highlight the significant association between certain antibiotics, particularly fluoroquinolones and beta-lactams, and the development of dysbiosis, aligning with existing literature on their disruptive effects on gut microbiota. The high percentage of serious reactions underscores the clinical importance of monitoring and managing dysbiosis as a potential AEs.

Keywords: Dysbiosis, Adverse events, Antibiotics, Pharmacovigilance