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Possible Zidovudine-lnduced Hepatotoxicity

Andra J. Melamed, PharmD; Raymond J. Muller, MS; Jonathan W. M. Gold, MD; Suzanne Wise Campbell, RN; Michael L. Kleinberg, MS; Donald Armstrong, MD
JAMA. 1987;258(15):2063. doi:10.1001/jama.1987.03400150055019.
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To the Editor.—  Zidovudine (azidothymidine) received Food and Drug Administration marketing approval on March 19, 1987. Before this, we received zidovudine from the National Institutes of Health for treating patients with acquired immunodeficiency syndrome who had recovered from one or more episodes of histologically confirmed Pneumocystis carinii pneumonia.To date, the most serious side effects that have been reported for zidovudine include severe anemia, granulocytopenia, or thrombocytopenia, sometimes requiring recurrent transfusions or interruption of therapy. Other reported side effects include rashes, asthenia, nausea, insomnia, myalgia, headache, and confusion.1-4 Hepatic enzyme abnormalities in both placebo and zidovudine recipients were reported by Richman and colleagues.4 They observed an aspartate aminotransferase (AST) concentration above 2500 U/L in one of 145 zidovudine recipients, while in 7% of the placebo recipients the AST concentration rose above 2500 U/L. Elevations of alkaline phosphatase concentration were also more common in placebo recipients.Since October 1986,

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