The Pharmaceutical Journal
Vol 277 No 7483 p706
22/29 December 2007

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News summary

Updated warnings needed for varenicline

Updated warnings are needed to increase prescribers’ awareness of depression in patients taking varenicline (Champix) to help them stop smoking, the European Medicines Agency (EMEA) announced last week. The EMEA has received reports of depression occurring in patients taking varenicline, with suicidal ideation and suicide attempt among the symptoms of this depression.

The EMEA’s Committee for Medicinal Products for Human Use has recommended that the following warning be added to the summary of product characteristics for Champix: “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.”

Patients taking varenicline who develop suicidal thoughts should stop treatment and contact their doctor immediately, the EMEA advises.

Champix manufacturer Pfizer believes there is no scientific evidence establishing a causal relationship between varenicline and the reported events. Nevertheless, the company has committed to work closely with the EMEA to review the post-marketing reports.

Pfizer stated: “In the post-marketing reports, not all patients had known pre-existing psychiatric illness and not all had discontinued smoking. The role of Champix in these reports is not known.”