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

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