European regulators are calling for a suicide warning to be including on packaging for the stop-smoking drug Champix (varenicline), Medical News Today reported Dec. 17.

The European Medicines Agency (EMEA) said the warning should note that some Champix users have had suicidal thoughts and attempted suicide. The drug, made by Pfizer, has been on the market in Europe since September 2006, and since then regulators have received numerous reports linking the drug to suicides.

The U.S. Food and Drug Administration also warned patients about possible links between the drug -- sold as Chantix in the U.S. -- and depression and suicide in a November 2007 alert.

The proposed European warning would state: "Depressed mood may be a symptom of nicotine withdrawal. Depression, including suicidal ideation and suicide attempt, has been reported in patients undergoing a smoking cessation attempt. These symptoms have also been reported while attempting to quit smoking with Champix. Clinicians should be aware of the possible emergence of significant depressive symptomatology in patients undergoing a smoking cessation attempt, and should advise patients accordingly."