Drug Safety Update

Volume 1, Issue 12 July 2008

Latest advice for medicines users

This article has been superseded

Please see new article: Varenicline: adverse psychiatric reactions, including depression (November 2008)

Varenicline: suicidal thoughts and behaviour

Article date: July 2008
Summary
Suicidal thoughts and behaviour have been reported in users of varenicline who have no known pre-existing psychiatric conditions, and while they continue to smoke. Anyone taking varenicline who develops depression or suicidal thoughts should stop their treatment and contact their doctor immediately

Varenicline (Champix ▼) is an aid to smoking cessation and was launched in the UK in December 2006. It is a partial agonist at the nicotinic α4 β2 receptor and can help to relieve the cravings and nicotine withdrawal symptoms associated with stopping smoking. Up to the end of March 2008, about 366 000 people had used varenicline in the UK.

Suicidal thoughts and behaviour

Stopping smoking—with or without medication—may be associated with various psychiatric symptoms, such as depressed mood, irritability, anxiety, frustration, or anger. Moreover, stopping smoking may exacerbate an underlying psychiatric condition.

Recently, concerns have arisen about reports of suicidal ideation and suicidal behaviour associated with the use of varenicline. Up to March 18, 2008, we have received 129 reports of suicidal thoughts or behaviour associated with the use of varenicline:

Suicide-related event Number of events
Completed suicide 2
Suicide attempt 4
Suicidal behaviour 4
Suicidal ideation 118
Suicidal depression 5

Footnote: Note that the sum of the number of suicide-related events exceeds the total number of reports of suicide-related events for varenicline because some reports may contain more than one suicide-related event.

These reports mainly involved people who had pre-existing psychiatric conditions or other psychosocial risk factors. However, a detailed review of UK Yellow Card data found that suicide-related events have been reported in patients taking varenicline who have no known pre-existing psychiatric conditions and in patients who continued to smoke.

Product information for doctors and patients has been updated to reflect these additional findings.

Advice for healthcare professionals:

  • Patients should be told to stop treatment and contact their doctor immediately if they develop suicidal thoughts or behaviour
  • Varenicline should be stopped immediately if agitation, depressed mood, or changes in behaviour are observed that are of concern to the patient, family, or caregivers
  • The safety and efficacy of varenicline in people with serious psychiatric illness have not been established. Patients who have a history of psychiatric illness should be monitored closely while taking varenicline

Please continue to report to us via the Yellow Card Scheme all reactions that you suspect may be related to the use of varenicline—including any considered not to be serious and reactions that are well-recognised. You do not have to be certain about causality; if in doubt, please report.

To help us with our further evaluation of this issue we ask that when reporting suicide-related events for varenicline, please include the following information where known:

  • Smoking status at the time of onset of the event
  • Presence or absence of any relevant pre-existing psychiatric illness
  • Presence or absence of any significant psychosocial stressors
  • Information on previous smoking-cessation attempts: smoking-cessation aids used (if any) and any nicotine-withdrawal symptoms or adverse effects experienced

 

Article citation: Drug Safety Update Jul 2008; Vol 1, Issue 12: 2

References

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Page last modified: 21 September 2010