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- Title
Clinical pattern of zileuton-associated liver injury: results of a 12-month study in patients with chronic asthma.
- Authors
Watkins, Paul B; Dube, Louise M; Walton-Bowen, Karen; Cameron, Christopher M; Kasten, Linda E
- Abstract
Zileuton is a 5-lipoxygenase inhibitor approved by the US FDA in 1996 for the treatment of asthma in adults and children. During phase II/III clinical trials, zileuton was generally well tolerated, although elevations in ALT and AST levels were noted in some patients, and a single treated patient developed hepatocellular jaundice. To more fully characterise the hepatic effects of zileuton, and to establish appropriate monitoring guidelines, a 12-month open-label, safety surveillance study was conducted prior to FDA approval.
- Publication
Drug safety, 2007, Vol 30, Issue 9, p805
- ISSN
0114-5916
- Publication type
Journal Article
- DOI
10.2165/00002018-200730090-00006