Public Citizen to FDA: Do Not Remove Chantix Black Box Warning

Sept. 14, 2016


Public Citizen to FDA: Do Not Remove Chantix Black Box Warning

Smoking Cessation Medication Can Cause Psychiatric and Neurologic Side Effects

The black box warning on the label for Chantix, a medication that helps people stop smoking, should not be removed because the product can cause potentially life-threatening psychiatric and neurologic side effects, Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group, said in testimony today.

Almashat testified before a combined meeting of two U.S. Food and Drug Administration (FDA) advisory committees, which convened to discuss removing Chantix’s (varenicline) black box warning. The committees are considering whether the FDA should remove the warning based on a single clinical trial that was fundamentally flawed and incapable of detecting the increased risk of such side effects, thousands of which have been reported to the FDA.

Read the testimony.

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