EMEA recommends update on Champix label

The European Medicines Agency (EMEA) has concluded that updated warnings to doctors and patients are needed to increase awareness of cases of suicidal ideation and suicide attempts reported in patients using world drug giant Pfizer's Champix (varenicline), a medicine indicated for smoking cessation in adults.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has been monitoring the safety of Champix since it was first authorized in the European Union in September 2006. As part of the routine pharmacovigilance activities, all adverse reactions for Champix are analyzed on a regular basis. Cases of suicidal ideation and suicide were reviewed in July, October and November 2007. At its December meeting, the CHMP concluded that there is a need to update the product information for Champix to warn doctors and patients that depression has been reported in people who are trying to stop smoking using this drug. The symptoms of this depression may include suicidal ideation and suicide attempt.

The CHMP has requested that the marketing authorization holder, Pfizer, submits a variation for Champix before December 19, 2007, to implement these changes to the product information. The EMEA will continue to keep this issue under close scrutiny and take appropriate actions if further concerns arise.