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Ann Pharmacother. 2007 May;41(5):755-63. Epub 2007 Apr 24.

Adverse effects of voriconazole: analysis of the French Pharmacovigilance Database.

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1
Department of Medical Pharmacology and Toxicology, Lapeyronie Hospital, Montpellier, France.

Abstract

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 (approximately 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.

PMID:
17456542
DOI:
10.1345/aph.1H671
[Indexed for MEDLINE]
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