Itraconazole and Fluconazole and Certain Rare, Serious Adverse Events

Bradbury, Brian D.; Jick, Susan S.

doi:10.1592/phco.22.9.697.34072

Cited by 33 publications

(16 citation statements)

References 9 publications

(3 reference statements)

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“…These findings, which are in accordance with the results from previous meta-analyses and population-based studies, suggest that fluconazole is well-tolerated and safe (9,28). We also observed that the use of echinocandins is associated with a lower risk of liver injury.…”

Section: Resultssupporting

confidence: 92%

“…In this study, we found that 19% of patients terminated itraconazole treatment due to an adverse reaction and 1.5% stopped due to hepatotoxicity, similar to the proportions of the high incidence of liver injury reported previously (9,28). Furthermore, voriconazole seemed to present a higher risk of liver injury, even though voriconazole use may not lead to treatment discontinuation.…”

Section: Resultssupporting

confidence: 84%

See 1 more Smart Citation

Systematic Review and Meta-Analysis of the Tolerability and Hepatotoxicity of Antifungals in Empirical and Definitive Therapy for Invasive Fungal Infection

Wang

Chang

Young‐Xu³

et al. 2010

Antimicrob Agents Chemother

145

137

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To evaluate the tolerability and liver safety profiles of the systemic antifungal agents commonly used for the treatment of invasive fungal infection, we conducted a systematic review and meta-analysis of randomized controlled trials published before 31 August 2009. Two reviewers independently applied selection criteria, performed quality assessment, and extracted data. We used the beta-binomial model to account for variation across studies and the maximum likelihood method to estimate the pooled risks. We identified 39 studies with more than 8,000 enrolled patients for planned comparisons. The incidence rates of treatment discontinuation due to adverse reactions and liver injury associated with antifungal therapy ranged widely. The pooled risks of treatment discontinuation due to adverse reactions were above 10% for amphotericin B formulations and itraconazole, whereas they were 2.5% to 3.8% for fluconazole, caspofungin, and micafungin. We found that 1.5% of the patients stopped itraconazole treatment due to hepatotoxicity. Furthermore, 19.7% of voriconazole users and 17.4% of itraconazole users had elevated serum liver enzyme levels, although they did not require treatment discontinuation, whereas 2.0% or 9.3% of fluconazole and echinocandin users had elevated serum liver enzyme levels but did not require treatment discontinuation. The results were similar when we stratified the data by empirical or definitive antifungal therapy. Possible explanations for antifungal agent-related hepatotoxicity were confounded by antifungal prescription to patients with a high risk of liver injury, the increased chance of detection of hepatotoxicity due to prolonged treatment, or the pharmacological entity.Invasive fungal infection is a leading cause of morbidity and mortality among immunocompromised and debilitated patients, including those with hematological malignancy, solid organ or bone marrow transplantation, and neutropenia and those receiving systemic corticosteroid therapy. Candida species and Aspergillus species are the two predominant causative fungi, with the case fatality rates being 30% and 50% among those infected with members of these two fungal genera, respectively (19,53). Over the past few decades, amphotericin B has been the mainstay treatment of candidiasis and aspergillosis, whereas fluconazole has been extensively used among patients with Candida albicans infection. After randomized controlled trials showed that extended-spectrum azoles (itraconazole, voriconazole, posaconazole) and echinocandins (anidulafungin, caspofungin, micafungin) had efficacies similar to those of amphotericin B and fluconazole, these newer antifungal agents have been used more frequently for the treatment of patients with probable or proven invasive fungal infection (18,32,56,59,81). Current practice guidelines recommend amphotericin B formulations, fluconazole, and echinocandins as first-line therapy for patients with candidemia; and amphotericin B formulations or voriconazole are the drugs of choice for the primary therapy of i...

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Section: Resultssupporting

confidence: 92%

Section: Resultssupporting

confidence: 84%

Systematic Review and Meta-Analysis of the Tolerability and Hepatotoxicity of Antifungals in Empirical and Definitive Therapy for Invasive Fungal Infection

Wang

Chang

Young‐Xu³

et al. 2010

Antimicrob Agents Chemother

145

137

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“…Both NVP and FLU are potential causes of hepatitis. However, there have been rare cases of serious hepatic reactions from FLU [26,27]. In this patient, only NVP-based ART was discontinued and then the liver function test had returned to be normal within three weeks.…”

Section: Discussionmentioning

confidence: 99%

Plasma nevirapine levels, adverse events and efficacy of antiretroviral therapy among HIV-infected patients concurrently receiving nevirapine-based antiretroviral therapy and fluconazole

et al. 2007

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“…The incidence of serious, adverse liver events was approximately 3.2/100 000 prescriptions of ITR, which proved that ITR rarely induces serious effect on the liver, kidneys, skin, or blood. [68,69] In 45 reports we reviewed, 23 were case reports on 42 infants, and the remaining were cohort or control studies of infants (the number was not clear). No adverse events were described in the case reports except mild diarrhea became moderate in one infant.…”

Section: Safetymentioning

confidence: 99%

Efficacy and safety of itraconazole use in infants

et al. 2016

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Itraconazole and Fluconazole and Certain Rare, Serious Adverse Events

Abstract: Itraconazole and fluconazole do not commonly cause rare, serious adverse events affecting the liver, kidneys, skin, or blood.

Cited by 33 publications

References 9 publications

Systematic Review and Meta-Analysis of the Tolerability and Hepatotoxicity of Antifungals in Empirical and Definitive Therapy for Invasive Fungal Infection

Systematic Review and Meta-Analysis of the Tolerability and Hepatotoxicity of Antifungals in Empirical and Definitive Therapy for Invasive Fungal Infection

Plasma nevirapine levels, adverse events and efficacy of antiretroviral therapy among HIV-infected patients concurrently receiving nevirapine-based antiretroviral therapy and fluconazole

Efficacy and safety of itraconazole use in infants

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