EMEA: New Warnings for Champix Needed

The European Medicines Agency (EMEA) has asked Pfizer to update warnings to doctors and patients on suicidal thoughts and attempted suicides reported with the use of Champix, a medicine indicated for smoking cessation in adults.

The Committee for Medicinal Products for Human Use (CHMP) has monitored the safety of Champix (varenicline) since it was first authorized in the European Union in September 2006.

At its December meeting, the CHMP concluded there is a need to update the product information for Champix, which is known as Chantix in the U.S., to warn doctors and patients that depression has been reported in patients who are trying to stop smoking using the drug.

The committee has requested that Pfizer submit a variation to the marketing authorization before Dec. 19, according to the EMEA.