Psychiatric Side Effects of Chantix to be Reviewed in Fall: FDA
MONDAY, April 28, 2014 -- The mental health risks associated with the anti-smoking drug Chantix will be reviewed at a public meeting scheduled for October, the U.S. Food and Drug Administration says.
The meeting will feature a panel of experts who will discuss the psychiatric and behavioral side effects of the pill and how best to manage them, the agency announced Friday, The New York Times reported.
In 2009, the FDA ordered drug maker Pfizer to add a black box label -- the strongest safety warning -- to Chantix after it was linked to hostility, aggression, depression and suicidal thoughts. There were dozens of reports of suicide and suicidal behavior among people taking the drug.
Pfizer was also told to conduct further studies to assess the extent of these side effects. The company recently provided the FDA with new data about the anti-smoking drug.
"Pfizer has proposed an update to the Chantix labeling based on these new data, which, we believe, would better reflect the product's safety profile as it pertains to neuropsychiatric symptoms," company spokeswoman Victoria Davis said in a statement, The Times reported.
The findings submitted to the FDA include data from a number of Pfizer studies, as well as findings from two studies conducted by the U.S. Department of Defense and the Department of Veterans Affairs.
The government studies were released in 2011 and found that Chantix users did not have a higher rate of psychiatric hospitalizations than those who used nicotine patches or other treatments to help them stop smoking. However, the study authors said only mental health problems that resulted in hospitalization were included, which means many such problems likely went unreported, the Times said.
U.S. sales of Chantix began in 2006 and the FDA began investigating the drug's potential side effects in 2007. The pill's labeling tells patients to stop using it if they develop agitation, depression, suicidal thinking and other behavioral changes.
Chantix works by blocking nicotine from binding to certain locations in the brain and triggering the release of the "feel-good" chemical dopamine.
Posted: April 2014