Chantix varenicline regulatory update

FDA's Psychopharmacologic Drugs Advisory and Drug Safety and Risk Management Advisory committees will meet on Oct. 16 to discuss the risk of serious neuropsychiatric adverse events with Chantix varenicline for smoking cessation and options for addressing this risk. In 2011, researchers at the Institute for Safe Medication Practices and colleagues reported data from an analysis of FDA's Adverse Event Reporting System (AERS) showing that Chantix was associated with a significantly increased risk of suicidal/self-injurious behavior and depression vs. other smoking-cessation products (see BioCentury, Nov. 7, 2011). ...