Anti-smoking pill linked to suicides

AN ANTI-SMOKING drug widely available in Ireland will not be removed from the market after being linked with more than 400 cases of suicidal behaviour in the US.

However, the drug, called Champix in Europe and Chantix in the US, which has been available on prescription here for more than a year, will carry a stronger warning.

The US Food and Drug Administration said it was “increasingly likely” the drug might be linked with serious psychiatric symptoms.

The FDA said it was aware of 39 suicides associated with drug.

Drug manufacturers Pfizer has updated the label on the drug in the US warning patients should be observed for potential “neuropsychiatric” symptoms, including changes in behaviour, agitation, depressed mood, suicidal thoughts and suicidal behaviour.

Pfizer said a causal relationship between the drug and the symptoms had not been established but admitted in some reports an association could not be excluded.

The drug, approved by the FDA in May 2006, works by targeting nicotine receptors in the brain, reducing cravings and withdrawal symptoms. It also reduces the pleasure of smoking.

The Irish Medicines Board confirmed yesterday the drug would carry a stronger warning here but was not being withdrawn.

The warning will point out that depression, including suicidal ideation and suicide attempt have been reported by patients while attempting to quit smoking with Champix and urges doctors to be aware of these “significant” depressive symptoms.

The FDA said the drug had been proven to be effective in smokers motivated to quit but patients and doctors needed the latest safety information to make an informed decision as to whether or not to use this product.

The IMB participated in a review of the drug at EU level by the European Medicines Agency last December.

The EMEA noted product information for Champix did not contain any warning about suicidal thoughts.

An IMB spokesperson said the warning was being added by Pfizer to information about the drug.

The Irish Cancer Society’s health promotion manager, Norma Cronin, said the society was, in principal, supportive of evidence-based methods of quitting and, to date, Champix had proven to be effective in smokers motivated to quit.

However, she urged patients and doctors to be aware of the latest safety information.

“Patients should always talk to their doctor about a drugs safety and efficacy profile and, in this instance, about the new information relating to Champix,” said Ms Cronin.