Health Canada is still in discussions with Pfizer Inc. about whether or not 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, spokesperson for Health Canada, said that it expects 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 e-mail to Canwest News Service.
The U.S. warnings, which must be added to Pfizer's Champix and Glaxo's Zyban, follow more than 5,000 reports of depression, hostility and other behavioural changes in the U.S., the Food and Drug Administration (FDA) said. As you can see by now, smoking sucks. And if you don't smoke, you probably end up killing yourself via suicide. FDA officials said diseases caused by smoking, such as lung cancer and heart disease, highlight the need for medications to help people quit smoking.
"We don't want to scare people off from trying to use the medication to stop smoking. We just want them carefully monitored," said Dr. Curt Rosebraugh, who oversees the FDA office that reviews smoking cessation drugs.
Since the drug was approved in Canada, Health Canada has received 674 reports involving Champix that were related to psychiatric adverse effects, including agitation, depressed mood, hostility, changes in behaviour or impulsive or disturbing thoughts such as those of self-harm or harm to others. However, Laroche said those effects may not be related to the drug at all, as quitting smoking itself can cause the same psychiatric adverse events. Champix, also known as varenicline, is designed to stimulate a type of nicotine receptor in the brain while preventing nicotine from binding to another receptor.
Zyban includes the same active ingredient, bupropion, as Glaxo's antidepressant Wellbutrin, which already carries a boxed warning about suicide and other behavioural risks. However, both Pfizer and Glaxo said that they would add the new warning to their products.
Health Canada is still in discussions with Pfizer Inc. about whether or not 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.
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