PMID- 35232318
OWN - NLM
STAT- MEDLINE
DCOM- 20220907
LR  - 20220907
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 21
IP  - 8
DP  - 2022 Aug
TI  - Hepatic safety of the antifungal triazole agent posaconazole: characterization of 
      adverse event reports in a manufacturer's safety database.
PG  - 1113-1120
LID - 10.1080/14740338.2022.2047177 [doi]
AB  - BACKGROUND: Second generation triazoles including posaconazole are efficacious 
      for prophylaxis and salvage treatment of life-threatening invasive fungal 
      diseases but have been associated with hepatic adverse events (AEs). This report 
      evaluated hepatic AEs in posaconazole-treated patients. RESEARCH DESIGN AND 
      METHODS: Hepatobiliary AEs occurring after posaconazole exposure in the company's 
      global safety database were analyzed to characterize underlying medical 
      conditions and concomitant drug exposure. RESULTS: As of October 2019, 516 cases 
      (168 from clinical trials, 348 from postmarketing use) containing 618 
      hepatobiliary AEs were reported regardless of causality. Frequently reported 
      terms were hyperbilirubinemia, hepatic failure, and hepatic function abnormal 
      (clinical trial reports) and hepatotoxicity, hepatocellular injury, and hepatic 
      function abnormal (postmarketing reports). Cases reporting concurrent medications 
      associated with drug-induced liver injury (DILI) included 8% with verified severe 
      DILI (vMost-DILI) concern, 24% with verified mild to moderate DILI (vLess-DILI) 
      concern, and 37% received both vMost-DILI and vLess-DILI-concern medications in 
      the DILIrank data set. CONCLUSIONS: Use of concomitant medications with known 
      risks for hepatic injury appears to be an important contributor for the 
      development of hepatotoxicity in patients treated with posaconazole.
FAU - O'Flynn, Rose
AU  - O'Flynn R
AD  - Clinical Safety and Risk Management, Merck & Co. Inc, Kenilworth, NJ, USA.
FAU - Zhou, Yun-Ping
AU  - Zhou YP
AD  - Clinical Safety and Risk Management, Merck & Co. Inc, Kenilworth, NJ, USA.
FAU - Waskin, Hetty
AU  - Waskin H
AD  - Clinical Safety and Risk Management, Merck & Co. Inc, Kenilworth, NJ, USA.
FAU - Leong, Ronald
AU  - Leong R
AD  - Clinical Safety and Risk Management, Merck & Co. Inc, Kenilworth, NJ, USA.
FAU - Straus, Walter
AU  - Straus W
AD  - Clinical Safety and Risk Management, Merck & Co. Inc, Kenilworth, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20220314
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Antifungal Agents)
RN  - 0 (Triazoles)
RN  - 6TK1G07BHZ (posaconazole)
SB  - IM
MH  - Antifungal Agents/adverse effects
MH  - *Chemical and Drug Induced Liver Injury/epidemiology/etiology
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - *Invasive Fungal Infections/drug therapy
MH  - Triazoles/adverse effects
OTO - NOTNLM
OT  - Posaconazole
OT  - adverse reactions
OT  - antifungals
OT  - azole antifungals
OT  - liver toxicity
EDAT- 2022/03/03 06:00
MHDA- 2022/09/08 06:00
CRDT- 2022/03/02 05:44
PHST- 2022/03/03 06:00 [pubmed]
PHST- 2022/09/08 06:00 [medline]
PHST- 2022/03/02 05:44 [entrez]
AID - 10.1080/14740338.2022.2047177 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2022 Aug;21(8):1113-1120. doi: 
      10.1080/14740338.2022.2047177. Epub 2022 Mar 14.