Adverse effects of voriconazole:: Analysis of the French pharmacovigilance database

被引:95
作者
Eiden, Celine
Peyriere, Helene
Cociglio, Marylene
Djezzar, Samira
Hansel, Sylvie
Blayac, Jean-Pierre
Hillaire-Buys, Dominique
机构
[1] Hop Lapeyronie, Dept Med Pharmacol & Toxicol, Montpellier, France
[2] Hop Lapeyronie, Dept Pharm, Montpellier, France
[3] Fernand Widal Hosp, Pharmacovigilance Ctr, Paris, France
关键词
adverse drug effects; pharmacovigilance; voriconazole; INVASIVE FUNGAL-INFECTIONS; DE-POINTES; PHARMACOKINETICS; SAFETY; CYCLOSPORINE; METABOLISM; EVENTS; RISK;
D O I
10.1345/aph.1H671
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
BACKGROUND: The most common adverse effects of voriconazole reported during clinical trials were disturbances of vision (30% of pts.), skin rashes (17.3%), and elevations in hepatic enzymes level (similar to 10% of pts.; varying with enzymes). However, postmarketing data concerning safety of voriconazole are limited. OBJECTIVE: To describe voriconazole adverse drug effects (ADEs) after 4 years of the drug's availability in France and determine their occurrence. METHODS: All cases of ADEs including voriconazole reported to the French Pharmacovigilance Database between 2002 and 2005 were analyzed. For each case, the following data were recorded: age, sex, indication, concomitant disease, concomitant medications, and ADE description. Causality link between voriconazole and ADEs was performed using the Naranjo probability scale. RESULTS: A total of 227 ADE cases were reported in 178 adults and 9 children (< 12 y), with 66% occurring in males. The patients' median age was 49.6 (2-80) years. ADEs included liver function test abnormalities (23%), visual disturbances (18%), skin rashes (17%), neurologic disturbances (14%), cardiovascular events (10%), hematologic disorders (8%), and renal disturbances (4%). Other less commonly identified ADEs included headache, nausea, vomiting, and diarrhea. Drug-drug interactions were observed in 7 cases. According to the Naranjo criteria, 84% of ADEs were classified as possible, 7% as probable, 5% as highly probable, and 4% as doubtful. CONCLUSIONS: Most ADEs found in this study are well documented in the literature, except for cardiac complications, which are rarely reported. Few ADEs related to drug interactions were observed; however, due to the extensive metabolism of voriconazole by cytochrome P450 isoenzymes, clinicians should be aware of potential interactions between voriconazole and other drugs metabolized through this pathway.
引用
收藏
页码:755 / 763
页数:9
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