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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For many smokers trying to kick their addiction, the latest news about the dangers of Pfizer’s smoking-cessation drug Chantix presents as a damned if you do, damned if you don’t dilemma. The U.S. Food and Drug Administration issued an alert yesterday, warning that use of the popular drug could lead to increased risk of heart attack and other adverse cardiovascular events.

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A senior scientist working for the non-profit Institute for Safe Medicine Practices has discovered that Chantix is a much more dangerous drug than has been officially acknowledged after finding hundreds of serious adverse reactions were reported to the FDA by manufacturer Pfizer Inc. through improper channels.

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Chantix made an appearance in last week’s issue of the Journal of the American Medical Association (JAMA) when one contributor wrote that the Food and Drug Administration has acknowledged receiving nearly 100 reports of suicide and nearly 200 reports of attempted suicide likely linked to the use of Chantix. Additionally, the FDA also said it is compliling reports of Chantix patients being involved in traffic accidents.

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I have that “born late” feeling. I quit smoking before I had a chance to “smoke” electronic cigarettes, the latest and most overtly sci-fi smoking cessation tool to come along in my lifetime. My first attempt to quit smoking was in 1989, 4 years after I started smoking, when my college roommate yanked a brand-new pack of smokes out of my hand and chucked them to the middle of a retaining pond near our New Mexico State dorm. I had given Keith my permission to do that or something like it “if you ever catch me with a pack of cigarettes again,” which was about seven hours earlier that same day.

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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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“It’s my mind-set this time,” Eric Wolbert told the St. Louis Post-Dispatch. “This time I’m going into it celebrating that I’m quitting rather than worrying about not being able to and how hard it was.”

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Last week, the Food and Drug Administration released a list of about 20 pharmaceutical drugs that the agency’s researchers are closely monitoring for potential safety concerns. Not surprisingly, Chantix (Varenicline) claimed a spot on the list. According to the FDA, the drug is being watched to determine whether it causes or contributes to angiodema (rapid and potentially life-threatening swelling of skin and tissue), other serious skin reactions, visual impairment, and accidental injury.

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The Milwaukee Journal Sentinel recently published a comprehensive report that exposes a very questionable relationship between the University of Wisconsin-Madison college of medicine and the drug industry. Using the University of Wisconsin-Madison as an example, the report describes how pharmaceutical companies have infiltrated the nation’s universities by funding physician education courses. Critics argue that the arrangement is unethical; when a college accepts hundreds of thousands or even millions of dollars in funds for such classes, the patrons expect something back. So what might appear superficially as a philanthropic gesture is actually an arrangement with lots of strings attached — an arrangement, critics say, that amounts to huge conflicts of interest.

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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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