Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Last month, the Food and Drug Administration warned of newly discovered cardiovascular risks associated with Pfizer’s popular smoking-cessation drug Chantix. But it turns out those risks, which include higher occurrence of heart attack and other adverse cardiovascular events in Chantix users with heart disease, pale in comparison to the findings of a larger study that found many of the same risks exist in Chantix patients with no heart disease.

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The U.S. Food and Drug Administration announced today that it will require drug manufacturers to put boxed warnings on the product labeling for Chantix (varenicline) and Zyban (bupropion hydrochloride, otherwise called Wellbutrin when prescribed as an antidepressant). Both Chantix and Zyban, commonly prescribed to patients as smoking cessation aids, have been linked to serious behavioral changes and other symptoms. Agitation, hostility, depression, and suicidal thoughts and actions are possible side effects that users should be keenly aware of, the FDA warns.

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Health Canada has received 818 reports of adverse side effects caused by the smoking cessation drug Chantix (marketed in Canada and elsewhere as Champix) since it first became available to Canadians nearly two years ago. The majority of complaints concerned psychiatric problems. Chantix is known to cause or exacerbate a spectrum of psychiatric and physical reactions, including moodiness, depression, violent behavior, lack of sleep, blackouts, and suicidal thought and actions.

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The Canadian Press reports that Health Canada, the government department responsible for Canada’s public health policies, is currently working with Pfizer to strengthen the warnings for the smoking cessation drug Chantix. Chantix is sold in Canada and elsewhere overseas under the name Champix.

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An investigative report aired by the British Broadcasting Company (BBC) tells the stories of two people who became suicidal after taking Chantix (marketed by Pfizer as Champix in Europe and the UK).

Chantix became available in the UK in December of 2006. Since then, nearly 400,000 prescriptions for the drug have been written.

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