PMID- 36545565
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221223
IS  - 2042-0986 (Print)
IS  - 2042-0994 (Electronic)
IS  - 2042-0986 (Linking)
VI  - 13
DP  - 2022
TI  - Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based 
      on FAERS.
PG  - 20420986221143266
LID - 10.1177/20420986221143266 [doi]
LID - 20420986221143266
AB  - BACKGROUND: Triazole antifungals are widely used as broad-spectrum antifungal 
      activity; however, there are many undetected and unreported adverse events (AEs). 
      METHODS: Data from the Food and Drug Administration Adverse Event Reporting 
      System (FAERS) from the first quarter (Q1) of 2004 to the third quarter (Q3) of 
      2021 were selected for disproportionality analysis to assess the connection 
      between antifungal triazoles, and AEs and important medical events (IMEs). 
      RESULTS: A total of 22,566 records associated with triazole antifungals were 
      identified, with 9584 triazole antifungal-IME pairs. The following system organ 
      classes (SOCs) appeared as significant signals: 'Endocrine disorders' [reported 
      odds ratio (ROR) = 167.94], 'Metabolism and nutrition disorders' (ROR = 46.30), 
      and 'Skin and subcutaneous tissue disorders' (ROR = 21.37). Strong signals were 
      observed with respiratory failure, rash, hepatic function abnormal, and 
      hypokalemia. Uncommon security signals included a change in the QT interval, 
      neurotoxicity, pseudoaldosteronism, and hallucinations. CONCLUSION: Various 
      triazole antifungals cause AEs of different types and intensities of association. 
      Our results are broadly consistent with prescribing information and previous 
      studies; however, additional pharmacoepidemiological studies are required to 
      verify AEs with modest incidence but high signal. PLAIN LANGUAGE SUMMARY: A study 
      on the adverse effects of triazole antifungals Introduction: The triazole 
      antifungals we studied include fluconazole, itraconazole, voriconazole, 
      posaconazole, and isavuconazole. Triazole antifungals are widely used as 
      broad-spectrum antifungals; however, there are many undetected and unreported 
      adverse events (AEs).Materials and Methods: The Food and Drug Administration 
      Adverse Event Reporting System (FAERS) database contains AEs reported to the FDA 
      by different countries regarding post-marketing drugs. Through the FAERS 
      database, we retrieved a total of 22,566 AE reports related to triazole 
      antifungals. We not only counted information about patients' gender, age, weight, 
      reporting country, outcome indicators, and indications but also analyzed the 
      system organ classes (SOCs) of AEs, and the number of reported drug-related AEs 
      and the degree of relevance.Results: We found a total of 22,566 records related 
      to triazole antifungal agents, of which 9584 reports made important medical 
      events (IMEs) about triazole antifungal agents, which are serious AEs. The 
      following SOCs appear as important signals: 'endocrine disorders', 'metabolic and 
      nutritional disorders', and 'skin and subcutaneous tissue disorders'. Triazole 
      antifungals produce AEs, such as respiratory failure, rash, hepatic function 
      abnormal, and hypokalemia. They also produce uncommon AEs, including changes in 
      the QT interval, neurotoxicity, pseudoaldosteronism, and 
      hallucinations.Conclusion: By analyzing data from the FAERS database, we 
      identified more AEs associated with these five triazole antifungals than were 
      indicated in the instructions and our findings provide additional insight into 
      triazole-related AEs to inform clinicians before and during treatment.
CI  - (c) The Author(s), 2022.
FAU - Chai, Shuang
AU  - Chai S
AUID- ORCID: 0000-0003-3809-3196
AD  - Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang, 
      China.
AD  - Department of the Second Clinical Pharmacy, School of Pharmacy, China Medical 
      University, Shenyang, China.
FAU - Zhan, Jing-Lun
AU  - Zhan JL
AD  - Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang, 
      China.
AD  - Department of the Second Clinical Pharmacy, School of Pharmacy, China Medical 
      University, Shenyang, China.
FAU - Zhao, Li-Mei
AU  - Zhao LM
AD  - Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang, 
      China.
AD  - Department of the Second Clinical Pharmacy, School of Pharmacy, China Medical 
      University, Shenyang, China.
FAU - Liu, Xiao-Dong
AU  - Liu XD
AD  - Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang 
      110004, China.
AD  - Department of the Second Clinical Pharmacy, School of Pharmacy, China Medical 
      University, Shenyang, China.
LA  - eng
PT  - Journal Article
DEP - 20221216
PL  - England
TA  - Ther Adv Drug Saf
JT  - Therapeutic advances in drug safety
JID - 101549074
PMC - PMC9761248
OTO - NOTNLM
OT  - FDA Adverse Event Reporting System
OT  - adverse drug events
OT  - azole antifungal
OT  - pharmacovigilance
OT  - system organ class
COIS- The authors declared no potential conflicts of interest with respect to the 
      research, authorship, and/or publication of this article.
EDAT- 2022/12/23 06:00
MHDA- 2022/12/23 06:01
PMCR- 2022/12/16
CRDT- 2022/12/22 02:42
PHST- 2022/07/19 00:00 [received]
PHST- 2022/11/15 00:00 [accepted]
PHST- 2022/12/22 02:42 [entrez]
PHST- 2022/12/23 06:00 [pubmed]
PHST- 2022/12/23 06:01 [medline]
PHST- 2022/12/16 00:00 [pmc-release]
AID - 10.1177_20420986221143266 [pii]
AID - 10.1177/20420986221143266 [doi]
PST - epublish
SO  - Ther Adv Drug Saf. 2022 Dec 16;13:20420986221143266. doi: 
      10.1177/20420986221143266. eCollection 2022.