Pfizer's Chantix May Cause Seizure & Suicidal Thoughts Says USFDA

Psfizer's proposal to get rid of Chantix's black-box warning label has been denied. The anti-smoking drug might have psychiatric side-effects, like suicidal thoughts, says the U.S. Food and Drug Administration. 

Chantix is an anti-smoking drug, chemically known as verenicline, which was released in 2006, reports Reuters. In addition, CBS DFW notes that the drug has been tagged with the FDA's strongest warning label since 2009. 

USFDA has warned that Chantix might cause seizures and other psychiatric side effects, reports Reuters. The department also warned against mixing the drug with alcohol as it can cause aggression in people or cause them to black out.  

The warning was issued Monday as a public notice after the administration updated the drug's label in September. Reuters explains that the cautionary advice was given so that patients are aware of the changes and consider the new information before trying Chantix. 

A black box highlights the warning. It states that taking the drug has neuropsychiatric side effects which include suicidal thoughts, hostility and agitation.  

CBS DFW reports that last year Pfizer sent a proposal to the FDA for the black-box warning to be removed. Pfizer's proposal was based on the company's own findings and other data, which seems to have concluded that Chantix had no psychiatric side effects. However, an FDA advisory committee denied the proposal in October. The administration had taken the time to examine studies on Chantix, which include the studies and analyses made by Pfizer, reports Reuters.  

The USFDA concluded that Pfizer's studies contained certain limitation. It said that the company did not research and examine all types of psychiatric problems, among other issues. Therefore, the administration could not make a decision about the safety of the drug based on Pfizer's research. 

Pfizer is currently conducting a larger study of Chantix's psychiatric side effects, reports CBS DFW. Reuters states that the FDA has decided to keep the black box warning until the data from the company's research have been released later this year. 

Because of the black-box warning, groups like the Federal Aviation Administration has banned Chantix for pilots and air traffic controllers.  

Patients on Chantix are also advised to stop consuming the drug if they begin to show signs of agitation, depression, or start having suicidal thoughts. Meanwhile, doctors prescribing the drug are asked to weigh Chantix's risks against its benefits.