FDA lights more fire under smoking-cessation drug Chantix

February 6, 2008

FDA issues public health advisory on varenicline

After sending out an Early Communication in November 2007 regarding reports of suicidality in patients taking findings, the FDA has asked Pfizer to increase the prominence of the potential serious neuropsychiatric symptoms in the warnings and precautions section of the product's prescribing information. The company will also finalize an official Medication Guide for distribution to patients. Patients should let their healthcare providers know if they have a history of psychiatric illness prior to taking the drug; healthcare professionals should monitor for changes in a patient's mood and behavior during treatment and report immediately to their provider if they occur, according to FDA. Varenicline was approved in 2006 as an aid to smoking cessation.

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