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

The black-box warning on Pfizer’s smoking-cessation drug Chantix (varenicline) just got bigger, following the results of a new study that found the drug caused an increased risk of heart attack and other adverse cardiac events in some patients. According to the U.S. Food and Drug Administration, the warning on Chantix labeling will include information about the safety and effectiveness of the drug in patients with existing cardiovascular disease and those with chronic obstructive pulmonary disease (COPD).

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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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It’s difficult for some coffee drinkers to imagine life before decaf. Pretty soon it may be difficult for some smokers to imagine life before de-nic. A New York company called 22nd Century Limited recently announced that it is making progress in its development of a very low nicotine (VLN) cigarette that uses a specially engineered and proprietary form of tobacco.

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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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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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