Pfizer Forced to Inform of Chantix Dangers

In July 2009, the U.S. Food and Drug Administration ordered Pfizer to include a warning on Chantix, to highlight the risk of serious mental health reactions and Chantix side effects, which include: changes in behavior, depressed mood, hostility and suicidal thoughts. Pfizer says the medication acts on sites in the brain affected by nicotine, helps ease withdrawal symptoms and blocks the effects of nicotine if a user resumes smoking. On June 16, the FDA issued a similar Chantix drug safety communication, warning that the smoking cessation drug might increase the risk of certain heart problems, including the risk of heart attack, among individuals who have cardiovascular disease. The warning came following the analysis of a study of 700 smokers that found those taking Chantix suffered twice the rate of heart attacks as those who did not.

Why would Pfizer spend $100 million on two-minute TV ads that use half of that time admitting that their drug Chantix can cause “changes in behavior, hostility, agitation, depressed mood,” “weird, unusual or strange dreams,” and “suicidal thoughts or actions”? Because they are required to do so. With the patent on Pfizer’s cash cow Lipitor expiring next year, Chantix, a smoking cessation pill, had been one of their big hopes for the future. Chantix sales in 2007 approached $900 million; by 2009, it accounted for 90 percent of smoking cessation prescriptions. But in 2009 the Food and Drug Administration, which approved Chantix in 2006, said it had received 4,762 reports of “serious psychiatric events”—including paranoia, homicidal thoughts, hallucinations, 188 attempted suicides and 98 Chantix suicides—and it ordered Pfizer to put a “black box” warning on the drug.

Despite the clear association between Chantix and violent behavior, Pfizer continues to defend their blockbuster medication and claims that there is no scientific evidence that Chantix has caused incidents of violent behavior. Although new warnings were added to the medication about the risk of suicide and other psychiatric side effects, not enough is being done to warn consumers and physicians about the risk of violent or aggressive behaviors with Chantix, which can have a devastating impact on their user and their family. Those affected by the adverse effects of Chantix are advised to contact an experienced Chantix lawyer as soon as possible.