More warnings about anti smoking drug Champix

Dec 20 2007

The European drugs regulator, the European Medicines Agency (EMEA) is calling for warnings to be placed on the the anti smoking drug Champix (varenicline).

The EMEA wants updates to the patient and doctor information about the drug's link to suicidal thoughts and behaviour.

The EMEA is also urging doctors to be particularly vigilant when prescribing Champix following reports that the drug may be associated with suicide attempts.

The drug helps relieve the cravings and withdrawal symptoms associated with stopping smoking and became available in the UK last year.

But it is already known to boost the risk of depression in patients with a history of mental illness and reports have raised concerns that the drug may be associated with suicidal thoughts and behaviour.

The call for an update on product information for doctors and patients follows a Europe wide review of all the available data on the drug’s use and its side effects by the Committee for Medicinal Products for Human Use (CHMP).

Last week EMEA asked the manufacturer Pfizer to update its product information by December 19 and warn doctors and patients that depression has been reported in patients who are trying to stop smoking using the drug and the symptoms may include suicidal ideation and suicide attempts.

Both the EMEA in Europe and the Food and Drug Administration in the U.S. have stressed the difficulty of finding out if the symptoms are due to varenicline, as people can become depressed when they stop smoking, whether they take a drug to help them or not.

Champix is marketed in the U.S. as Chantix and in November, the FDA issued a similar early communication, saying there had been a number of post-marketing reports, from the drug company, about patients having suicidal thoughts and behaving erratically while taking the drug.

Until better scientific information is available, the EMEA advises doctors to tell their patients that depression can be a side effect of giving up smoking, and patients on Champix who start to get suicidal thoughts should stop taking the drug and see their doctor at once.