Europe-wide review recommends updates to product information for varenicline (brand name Champix▼)

14 December 2007

Varenicline (brand name Champix▼) is a non-nicotine aid to smoking cessation that is authorised through one of the European licensing procedures, the centralised procedure. It can help to relieve the cravings and withdrawal symptoms associated with stopping smoking.

Champix was first marketed in the UK in December 2006 and since that time its safety has been monitored closely by the Medicines Healthcare products Regulatory Agency (MHRA) in conjunction with the European Medicines Agency (EMEA). Recently concerns have arisen about reports of suicidal thoughts and behaviour reported in association with the use of Champix and these data have been subject to Europe-wide review.  Following the most recent consideration of the available data it has been recommendation that the Champix product information for doctors and patients should be updated to contain warnings that depression has been reported in patients who are trying to stop smoking using Champix and that the symptoms of this depression may include suicidal thoughts and behaviour. These updates to the product information are ongoing.
 
The EMEA has issued a statement and Question and Answer  (external links) document about the action that is proposed, in which they advise that:

• Doctors are already aware of the risk of using Champix in patients who have an underlying mental illness. They also need to be aware of the possibility that patients who are trying to stop smoking can develop symptoms of depression, and they should advise their patients accordingly.
• Patients who are taking Champix and develop suicidal thoughts should stop their treatment and contact their doctor immediately.