FDA To Require Suicide Warning On Stop Smoking Drugs
(Washington, DC) -- The Food and Drug Administration will require a warning of the strongest possible kind on packaging for two smoking cessation drugs. The warning will deal with the risk of serious mental health problems including thoughts of suicide by those using Chantix and Zyban. For Chantix, the FDA has received 98 reports of suicides, 14 for Zyban. There have been nearly 200 reports of attempted suicides by Chantix users compared to none for nicotine-replacement products such as nicotine gum. In addition to the immediate change in labeling, the FDA will require the drugs' makers, Pfizer and GlaxoSmithKline, to conduct a clinical trial to try and determine how often users develop serious psychiatric symptoms. The companies are suggesting nicotine withdrawal rather than their drugs is the cause of mental issues in those trying to kick the habit. |