Quit Smoking Drug Safety Notice - Health Canada Update

Health Canada says it is in the process of strengthening safety information on the labels of the smoking-cessation product Champix.

In a statement Tuesday, it said it's working with the drugmaker Pfizer to update prescribing information after reports of serious psychiatric symptoms associated with the use of Champix.

Health Canada says label changes that increase awareness of the risk will be passed along to consumers and medical professionals when they are finalized.

Champix can be an effective tool for quitting smoking, it says, but there have been reports in some patients of unusual feelings of agitation, depressed mood, hostility, changes in behaviour, or impulsive or disturbing thoughts such as thoughts of self-harm or harm to others.

Health Canada says people taking the drug and their families are reminded to be aware of any unusual thoughts, feelings or behaviours, especially those related to depression, aggression or self-harm.

It isn't clear whether Champix is the cause of these psychiatric symptoms, but patients should stop the drug immediately if there are such concerns.

And patients should avoid driving or operating machinery until they're sure that Champix doesn't have an adverse effect on them, Health Canada said.

In issuing its reminder Tuesday, the federal agency noted that it's a time of year when many smokers are attempting to kick the habit.

In Montreal, Pfizer spokesman Christian Marcoux said that Champix is "safe and very efficacious" and that some symptoms are actually caused by the act of quitting smoking.

"Any individual attempting to quit smoking should be monitored and work with their physician because smoking cessation will generate or exacerbate such symptoms, with or without medication," he said.

He said the simple fact of quitting smoking will trigger behavioural changes.

"Smoking is a very nasty addiction and it's quite a challenge to work on that addiction," he said.
Source: CBC.ca, Health Canada

Anti-Smoking Drug's Adverse Effects

Smoking drug Champix linked to adverse psychiatric effects: Health Canada

Health Canada has issued a warning about adverse neuropsychiatric effects linked to Champix, a drug intended to help smokers butt out for good.

A number of patients taking Champix (varenicline tartrate) have experienced unusual feelings of agitation, depressed mood, hostility, changes in behaviour or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, Health Canada said Friday in an advisory.

The medication acts on sites in the brain affected by nicotine. The drug helps ease withdrawal symptoms and blocks the effects of nicotine if users resume smoking.

Champix, made by Pfizer Inc. and sold under the brand name Chantix in the United States, has been sold in Canada since April 2007. In the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported. In that period, more than 708,500 prescriptions for the drug have been filled across the country.

Health Canada issued the following guidelines to the public:

• Tell your doctor if you have experienced depression or other mental health problems before taking Champix, as these symptoms may worsen while taking the drug.
• Stop taking Champix and tell your doctor right away if you, your family or caregiver have noticed any of these symptoms, if you experienced these symptoms in a way that is not typical for you or if you have thoughts of self-harm or of harming others.
• Champix has not been studied in people with mental health problems, and therefore your doctor will be monitoring you closely for new or worsened emotional or behavioural problems while on the medication.

"Quitting smoking can also be associated with changes in mood and behaviour, with or without taking medication to help quit," said the federal department in its advisory. "A doctor or pharmacist should be consulted should these symptoms or those described above be experienced, since guidance has been provided to health-care professionals on how to use Champix in patients, including those patients who may also have mental health problems."

Health Canada, which published an article concerning Champix in the Canadian Adverse Reaction Newsletter in April, said any case of serious change in mood or behaviour or other serious or unexpected adverse reactions in patients receiving Champix should be reported.

Source:CBC.ca