Health Canada concludes from a recent safety review that hepatotoxicity remains an important safety concern for patients
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■ Health Canada concludes from a recent safety review that hepatotoxicity remains an important safety concern for patients using antiandrogens. Canadian labels for antiandrogens currently carry warnings regarding the risks of hepatotoxicity and liver failure. As of 31 March 2012, Health Canada had received 25 case reports of hepatoxicity suspected of being associated with the use of antiandrogens in men aged 60–98 years; 24 of these reports were considered serious. The department also received one report of hepatoxicity in a woman who was using an antiandrogen for hirsutism. Data from published clinical trials and from the Canada Vigilance database indicate that all of the antiandrogen products marketed in Canada are associated with some increased risk of hepatotoxicity; although, the frequency of these adverse reactions and their clinical features appears to differ between drugs. Health Canada. Antiandrogens and hepatotoxicity. Canadian Adverse Reaction Newsletter 22: 3-4, No. 4, 1 Oct 2012. Available from: URL: http://www.hc803078369 sc.gc.ca
0114-9954/10/1423-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 13 Oct 2012 No. 1423
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