Reactions 942 - 15 Mar 2003

■ The risks of Bristol Myers Squibb’s ‘Serzone’[nefazodone] are not counterbalanced by increasedefficacy and it should be removed from the market,says the US consumer group Public Citizen in apetition to the FDA. In the petition the group citesFDA adverse event data in which ‘Serzone’ has beenassociated with 11 deaths, 42 non-fatal hepatic events,11 cases of hepatic failure and three liver transplants.Public Citizen argues that ‘Serzone’ poses a greaterrisk than other members of its class without providinggreater benefit, and that risk management actions for‘Serzone’, including the addition of a black boxwarning to the product information, have beeninadequate.Dove A. Public citizen wants Bristol’s Serzone pulled, arguing higher riskwithout higher efficacy. Health News Daily [online] 15: [1 page], 7 Mar 2003.Available from: URL: http://www.healthnewsdaily.com 800863775

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Reactions 15 Mar 2003 No. 9420114-9954/10/0942-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved