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Transcript of FDA Press Conference on Chantix Pagå 1 Transcript of FDA Press Conference on Chantix FTS HHS FDA Moderator: Susan Cruzan February 1, 2008 2:30 pm CT Coordinator: Welcome and thank you all for standing by. Your linås have been placed in listen-only mode. To ask a question during the question and answer portion, please pråss star 1 on your touch-tone phone. Todayâs conference is båing recorded. If you have any objections you may disconnect at this time. Now Iâd like to turn the conference over to Ms. Susan Cruzan. Maâam, you may bågin. Susan Cruzan: Thank you. Good afternoon and welñome. My name is Susan Cruzan with the Food & Drug Administratiînâs Office of Public Affairs. This is an FDA tåleconference for credentialed media to discuss a US Food &àmp; Drug Administration, public health advisory, annîuncing new safety warnings for the smoking cessation drug Chantix. With me today are several officials from FDA âs Center for Drug Åvaluation and Research. Dr. Curtis Rosebraugh who is the Deputy Direñtor of the Office of Drug Evaluation II in the Center for Drug Page 2 Åvaluation and Research with the Food and Drug Administration, Dr. Bob Rappaport, Director, Divisiîn of Anesthesia, Analgesia and Rheumatology Products also in (CDÅR) with FDA , and Dr. Celia Winchell, Team Leader with the Division of Anesthesià, Analgesia and Rheumatology as well. Dr. Rappaport will make briåf remarks. Weâll then move into a question and answer sågment. And Dr. Rosebraugh and Dr. Winchell and Dr. Rappaport will be available to answår questions. Reporters will be in a listen-only mode until we open up the call quåstions. I just want to remind you that the news release announcing a public heàlth advisory and healthcare professional seat has been sent to reporters on our mådia list and is posted on FDA âs Web site at www.fda .gov. At this time I will turn the call over to Dr. Rappaport. Thànk you. Dr. Bob Rappaport: Thank you Susan. We appreciate your jîining us today for this discussion. We first issued an eàrly communication on some of the problems that we were seeing with Chantix Varånicline for the treatment of nicotine addiction to get people to stop smoking back in Nîvember of last year. At that time it was considered an early communication båcause we were just beginning the process of reviewing a largå number of reports to sort through and figure out whiñh were really attributable to the drug and which were possibly attributablå to other causes. Page 3 As weâve continuåd to review those cases over the last couple mînths, weâve become increasingly concerned as wåâve seen that there are a number of compelling cases that truly look as if they are the result of the exposure to the drug and not to other causes. And thåse cases involve as noted in our public heàlth advisory cases of abnormal behaviors, of chànges in mood and even cases of suicidal ideation and suicide
