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ARTICLE | Clinical News

GI panel: CV safety studies unnecessary

November 18, 2011 1:25 AM UTC

FDA's Gastrointestinal Drugs Advisory Committee on Thursday voted 17-4 with 1 abstention against requiring companies to conduct a dedicated cardiovascular safety trial of serotonin (5-HT4) receptor agonists for GI indications. Of the 10 cardiologists on the panel, 7 voted against and 3 voted for such a trial. Panelists voting against the requirement felt CV safety concerns could be addressed by including high-risk patients in Phase III trials and instituting a postmarketing pharmacovigilance program.

The majority of panel members were unconvinced that CV problems previously seen with 5-HT4 receptor agonists in GI indications were likely to be a class effect. They agreed that the QT prolongation and arrhythmias seen with heartburn treatment Propulsid cisapride were likely due to off-target effects and that coronary ischemic events seen with irritable bowel syndrome therapy Zelnorm tegaserod were not clearly associated with the drug. Propulsid, from Johnson & Johnson (NYSE:JNJ), and Zelnorm, from Novartis AG (NYSE:NVS; SIX:NOVN), were withdrawn due to the CV concerns. ...