Health Canada weighs options as U.S. FDA adds "black box" warnings

From the Ottawa Citizen:
Health Canada is still in discussions with Pfizer Inc., about whether to add safety warnings to packages containing anti-smoking drugs that may have psychiatric side effects, including suicidal thoughts.

South of the border, U.S. health officials Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems.

Philippe Laroche, spokesman for Health Canada, said the federal agency expect to reach an agreement with the pharmaceutical giant by the end of this summer, or the fall.

"In addition to updated safety information regarding the risk of psychiatric events, new labelling will also incorporate information regarding angioedema, serious skin reactions and accidental injury," said Laroche in an email to Canwest News Service.

The U.S. warnings, which must be added to Pfizer's Champix and Glaxo's Zyban, follow more than five thousand reports of depression, hostility and other behavioural changes in the U.S., the Food and Drug Administration said. ...more

Pfizer to set up 600 smoking cessation clinics in 2 years

It looks like Pfizer will opt for a more direct approach when they are selling Champix in India. With the relatively open pharmaceutical laws, it could work there. I wonder how objective these clinics will be. Nonetheless, it's an innovative concept.

From the Economic Times (India):
Pfizer India plans to launch 600 smoking cessation clinics across the country in the next two years in partnership with private sector hospitals and clinics. Pfizer India director (pharmaceutical marketing) Anjan Sen said: “We have already tied up with 150 clinics in 17 cities, including Max Healthcare, and are in talks with more hospitals for partnerships. We are also in talks with the government to use this as a treatment option in the 600 clinics that they plan to set up.”

The government had last year announced to launch same number of clinics. The government clinics will use nicotine replacement therapies (NRT) like chewing gum and patches, along with counselling, to help people quit smoking, a method that doctors say has far less success rate than medication which blocks the receptors in the brain absorbing nicotine.

According to Mr Sen, the government will shortly conduct a clinical trial of the Pfizer drug, Champix, to check its efficacy and if satisfied it will become a part of the government’s anti-smoking programme. ...more

Smoking-cessation drug under scrutiny

From CTV Calgary:
Hundreds of people claim a drug used to help people quit smoking has given them some serious side effects.

Dana Roy says she tried to slit her wrists while she was taking the drug Champix. She says "I looked down at the sink and this knife was sitting here, and I picked it up and cut both my wrists".

Roy says "I had such an overwhelming feeling of anxiety; I just wanted the feeling to go away".

Roy's medication did come with an information sheet that described common side effects such as nausea and trouble sleeping. It also said "tell your doctor if you experience agitation, depressed mood or suicidal thoughts" the sheet also says "it's not known if these symptoms are related to Champix". ...more

Health Canada Reminds Canadians of Important Safety Information For the Smoking-Cessation Aid Champix

From Health Canada:
Health Canada is reminding Canadians who are taking, or considering taking, the smoking-cessation aid Champix of important safety information for this product. Health Canada is also informing Canadians that it is in the process of further strengthening the labelling for the drug with respect to the risk of serious psychiatric adverse effects.

While Champix (the brand name for varenicline tartrate) can be an effective tool for quitting smoking when used as part of a support program, 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. It is unclear at this time whether Champix is the cause of these psychiatric symptoms. ...more

Champix side effects prompt 818 complaints

From the Globe and Mail:
Health Canada has received more than 800 reports of side effects - including more than 500 reports of psychiatric problems - linked to the controversial smoking-cessation drug Champix in less than two years on the market.

But although evidence is growing that the medication is linked to aggression, depression and suicidal tendencies, some tobacco-control experts and non-profit groups in Canada still encourage its use, often without mention of the possibility of psychiatric problems.

In its online guide to quitting smoking, forexample, the Canadian Lung Association includes a section that lists Champix first as an effective option to "reduce cravings and withdrawal symptoms."

The association says the "pros" of Champix include the fact it is in pill form and is easy to use, as well as the fact it is not addictive because it doesn't contain nicotine. The guide lists only minor side effects, such as nausea, strange dreams and constipation, as "cons" to taking Champix, even though Health Canada has issued two warnings in recent months about links between the drug and serious psychiatric side effects.

The smoking and tobacco section of the website indicates that Pfizer Canada, which sells Champix, provided funding to the association in the form of a restricted educational grant, which means that Pfizer isn't involved in how the money is spent. ...more

Quit-smoking aid may cause depression: Health Canada

From the Vancouver Sun:
Canadians who have made New Year’s resolutions to quite smoking should be careful about what types of smoking-cessation aids they choose, as Health Canada warned consumers Tuesday about the depressive side-effects from a certain product.

Health Canada issued a reminder to Canadians who are taking, or considering taking, the smoking-cessation aid called Champix, saying the drug has a risk of “serious psychiatric adverse effects.”

The federal health agency says it is still in the process of creating stronger wording on product labels to warn consumers of the risks.

“While Champix can be an effective tool for quitting smoking when used as part of a support program, 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,” the agency said in a news release Tuesday.

It is unclear at this time whether Champix is the cause of these psychiatric symptoms, said Health Canada.

Health Canada suggest those taking the drug should be aware of any unusual thoughts, especially those related to depression, aggression or self-harm. ...more

Anti-smoking drug Champix may spur depression, agitation

From CBC News:
Health Canada has issued another 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. ...more

Risk of depression dims hopes for new anti-addiction pills

From the Canadian Press:
Two years ago, Scientists had high hopes for new pills that would help people quit smoking, lose weight and maybe kick other tough addictions like alcohol and cocaine.

The pills worked in a novel way, by blocking pleasure centres in the brain that provide the feel-good response from smoking or eating. Now it seems the drugs may block pleasure too well, possibly raising the risk of depression and suicide.

Margaret Bastian of suburban Rochester, N.Y., was among patients who reported problems with Chantix, a highly touted quit-smoking pill from Pfizer Inc. that has been linked to dozens of reports of suicides and hundreds of suicidal behaviours. The product is sold as Champix in Canada and other countries.

"I started to get severely depressed and just going down into that hole ... the one you can't crawl out of," said Bastian, whose doctor took her off Chantix after she swallowed too many sleeping pills and other medicines one night. ...more

'Suicidal' urges among reactions to stop-smoking pill

From the Ottawa Citizen:
Nearly half of reported suspected drug reactions in people taking the popular anti-smoking pill Champix involve psychiatric reactions, including seven people who became suicidal while on the drug, a new federal report shows.

In the first eight months after Pfizer Inc. began marketing its smoking cessation drug last April, Health Canada received 107 reports of adverse drug reactions suspected of being associated with Champix.

Of these, 46 involved psychiatric reactions including aggression, depression and suicidal thinking. Others involved amnesia, abnormal dreams, anxiety, insomnia, and abnormal thinking. 'Suicidal' urges among reactions to stop-smoking pill

Smoking drug Champix's risks flagged

From the Globe and Mail:
Just one year after it was approved for use in Canada, federal health officials are investigating safety concerns about smoking cessation prescription drug Champix amid fears it is linked to suicide and serious psychological problems.

The investigation and reports of major side effects highlight what many medical experts describe as chronic problems with the way new drugs are approved in Canada and the ability of government officials to adequately monitor them once they're put on the market.

"Existing systems don't really seem to be adequate," said David Henry, chief executive officer of the Institute for Clinical Evaluative Sciences in Toronto. "That means often times the studies that are the basis for market approval are not large enough to test for safety properly." ...more

Quit-smoking drug linked to serious psychiatric side-effects: FDA

From the Canadian Press:
The U.S. Food and Drug Administration issued a public health warning Friday about a highly touted smoking cessation drug after it was linked to potentially serious neuropsychiatric symptoms.

Adverse effects have been reported in relation to the prescription medication Chantrix (varenicline), which is sold in Canada under the brand name Champix, including changes in behaviour, agitation, depressed mood, and suicidal thoughts and behaviour.

The FDA has requested that Pfizer, the drug's manufacturer, add the new safety information to the warnings and precautions section of the medication's prescribing information or labelling. The agency also is working with Pfizer to finalize a medication guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology products, said in an advisory. ...more