The European Medicines Agency (EMEA) has determined that doctors and patients need new information concerning the stop-smoking drug Champix. The agency feels that updated warnings are needed to increase awareness of the cases of suicidal thoughts and actions in adults using Champix to stop smoking.
The Committee for Medicinal Products for Human Use (CHMP) has been following Champix closely since its introduction into the EU in September of 2006. This group vigilantly monitors all cases of adverse reactions to drugs. In July, October, and November, adverse reactions, including thoughts of suicide, were noted by the organization. In their meeting this month, the committee has recommended that increased warnings be given to doctors and patients detailing the risk of depression while trying to stop smoking.
The symptoms of the depression exhibited by people on Champix included suicidal thoughts and actions. The committee has requested that the company which manufactures Champix, Pfizer, submit an updated version of their market authorization forms to the Committee that detail the new warnings by December 19th.