Chantix Psychiatric Side Effects Not Seen in FDA Studies

Two studies sponsored by the FDA failed to find a link between Pfizer’s smoking cessation drug Chantix and psychiatric problems, such as increased incidents of suicide and violent behavior. 

The FDA issued a Chantix drug safety communication on October 24, indicating that two epidemiological studies failed to find an increase in the risk of dangerous psychiatric side effects with Chantix use.

The findings run counter to a number of other reports that suggest Chantix side effects increase the risk of suicidal behavior, sudden outbursts of violence, depression, and other psychological problems.

The FDA noted that “both studies had a number of study design limitations,” the primary failing being that they only looked at psychological problems that resulted in hospitalization. Many of the known incidents of violence or suicide, including a number of murders believed to be linked to the drug, did not involve any subjects being hospitalized.

“Although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix,” the FDA concluded.

The FDA compared the rate of psychological problems suffered by Chantix users that resulted in hospitalization to those linked to other smoking cessation techniques, like nicotine patches.

The agency stated that it is continuing to evaluate risk of Chantix psychological side effects and Pfizer has started a large clinical trial to look at Chantix neuropsychiatric risks. However, those results will not be available until 2017.

Pfizer’s patent for Chantix expires in November 2018, at which point generic versions would become possible and the drug would likely lose its blockbuster money-making status.

Chantix (varenicline) was approved in the United States by the FDA in 2006, and works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the medication has been associated with a large number of reports involving behavioral changes, depression, aggression, agitation, hostility, rage, suicidal ideation, suicide attempts and, in many cases, successful suicide. Some research has also suggested it may increase the risk of heart attacks and other cardiovascular problems.

Hundreds of individuals throughout the United States are currently pursuing a Chantix lawsuit against Pfizer over serious injuries or death caused by suicide attempts or unusual, agressive behavior on Chantix. The complaints allege that Pfizer failed to adequately research the side effects of Chantix on people with mental illness and depression before releasing the medication.

Experts say that people suffering from depression and mental problems are more likely to smoke and more likely to have difficulties quitting on their own. However, Pfizer allegedly ignored FDA recommendations for Chantix testing on people with psychological problems.