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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WhyQuit, an organization that advocates quitting smoking using the cold turkey method, recently published an article that takes Pfizer to task over its latest Chantix ads. The group claims that the pharmaceutical company’s new television commercials hide information from the viewer – information that, if known, would likely dissuade most smokers from using the drug as a smoking cessation aid.

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The family of musician Carter Albrecht has filed a lawsuit in a Dallas federal court against Chantix manufacturer Pfizer Inc. Ken and Judy Albrecht allege that the drug manufacturer is responsible for the musician’s death in 2007 because it marketed Chantix, which Carter had been taking at the time of his death, while knowing it to be unsafe.

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The Food and Drug Administration has approved the new labeling for Chantix packaging. In July, we reported that the agency said it would require stronger warnings on all Chantix labeling, as well as packaging for other smoking cessation drugs Wellbutrin and Zyban (bupropion hydrochloride). All of the drugs have been linked to serious behavioral changes and other symptoms.

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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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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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Chantix has to be one of the most bipolar prescription drugs ever created. Every day, a search for the latest Chantix news digs up blogs written by fans of the smoking cessation drug, who often tout it as a miracle or a blessing in their struggle to become nonsmokers. Yet other users liken it to a nightmare or a curse, citing wild mood swings, disturbing dreams, and uncharacteristic thoughts of suicide.

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Researchers at the Institute for Safe Medicine Practices, a nonprofit organization, and Wake Forest University say that their latest review of Chantix data justifies stepping up warnings about the drug.

More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.

Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.

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