Doctors are being urged to be extra vigilant when prescribing the anti smoking drug Champix (varenicline), following reports that the drug may be associated with suicide attempts.
The drug, which helps relieve the cravings and withdrawal symptoms associated with stopping smoking, became available in the UK this time last year.
It is already known to boost the risk of depression in patients with a history of mental illness
But recent reports submitted to the UK and European drugs regulators as part of their monitoring schemes, have raised concerns that the drug may be associated with suicidal thoughts and behaviour.
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) has prompted an update of the product information for doctors and patients.
In a statement issued last week, the European drugs regulator, the European Medicines Agency (EMEA) through which the drug was licensed, said the agency had asked the manufacturer Pfizer to update its product information by December 19.
“At its December 2007 meeting, the CHMP concluded that there is a need to update the product information for Champix to warn doctors and patients that depression has been reported in patients who are trying to stop smoking using [the drug],” it said.
“The symptoms of this depression may include suicidal ideation and suicide attempts,” it continued.