Itraconazole and Fluconazole and Adverse Events
Itraconazole and Fluconazole and Adverse Events
Study Objective: To determine rates of drug-induced, rare, serious adverse events affecting the liver, kidneys, skin, or blood, occurring within 45 days of completing a prescription or refill for itraconazole or fluconazole.
Design: Population-based follow-up study.
Setting: United Kingdom-based General Practice Research Database.
Patients: Total of 54,803 users of either fluconazole or itraconazole.
Main Results: Four patients were identified with illnesses for which a drug-induced etiology could not be ruled out; one with an elevated liver function test while taking itraconazole, one with thrombocytopenia, one with neutropenia, and one with an abnormal liver function test just after receiving fluconazole. For itraconazole the rate was 3.2/100,000 prescriptions (95% confidence interval [CI] 0.6-17.9) for serious, adverse liver events; for fluconazole 2.8/100,000 prescriptions (95% CI 0.8-10.3) for serious, adverse blood events and 1.4/100,000 prescriptions (95% CI 0.25-8.2) for serious, adverse liver events.
Conclusion: Itraconazole and fluconazole do not commonly cause rare, serious adverse events affecting the liver, kidneys, skin, or blood.
Itraconazole is an antifungal agent given to combat systemic fungal infections. Two studies investigating its safety and efficacy reported mostly mild and reversible adverse events among a small percentage of users. A few case reports suggested a link between itraconazole and development of rhabdomyolysis, a muscle disorder. More recently, the United States Food and Drug Administration issued a public health advisory alerting physicians to the risk of congestive heart failure associated with the agent when administered for treatment of onychomycosis.
To date, no comprehensive population-based analysis has studied the association between treatment with itraconazole and fluconazole and development of uncommon, serious adverse events affecting the liver, kidneys, blood, or skin. To estimate rates of such disorders, we evaluated data in the United Kingdom-based General Practice Research Database (GPRD). Since 1987, over 4 million residents of the United Kingdom have been enrolled with selected general practitioners who provide data for research purposes to the GPRD. The database is described extensively elsewhere.
Study Objective: To determine rates of drug-induced, rare, serious adverse events affecting the liver, kidneys, skin, or blood, occurring within 45 days of completing a prescription or refill for itraconazole or fluconazole.
Design: Population-based follow-up study.
Setting: United Kingdom-based General Practice Research Database.
Patients: Total of 54,803 users of either fluconazole or itraconazole.
Main Results: Four patients were identified with illnesses for which a drug-induced etiology could not be ruled out; one with an elevated liver function test while taking itraconazole, one with thrombocytopenia, one with neutropenia, and one with an abnormal liver function test just after receiving fluconazole. For itraconazole the rate was 3.2/100,000 prescriptions (95% confidence interval [CI] 0.6-17.9) for serious, adverse liver events; for fluconazole 2.8/100,000 prescriptions (95% CI 0.8-10.3) for serious, adverse blood events and 1.4/100,000 prescriptions (95% CI 0.25-8.2) for serious, adverse liver events.
Conclusion: Itraconazole and fluconazole do not commonly cause rare, serious adverse events affecting the liver, kidneys, skin, or blood.
Itraconazole is an antifungal agent given to combat systemic fungal infections. Two studies investigating its safety and efficacy reported mostly mild and reversible adverse events among a small percentage of users. A few case reports suggested a link between itraconazole and development of rhabdomyolysis, a muscle disorder. More recently, the United States Food and Drug Administration issued a public health advisory alerting physicians to the risk of congestive heart failure associated with the agent when administered for treatment of onychomycosis.
To date, no comprehensive population-based analysis has studied the association between treatment with itraconazole and fluconazole and development of uncommon, serious adverse events affecting the liver, kidneys, blood, or skin. To estimate rates of such disorders, we evaluated data in the United Kingdom-based General Practice Research Database (GPRD). Since 1987, over 4 million residents of the United Kingdom have been enrolled with selected general practitioners who provide data for research purposes to the GPRD. The database is described extensively elsewhere.
