FDA won’t let Chantix think outside the black box

Fda Chantix

New York drug manufacturer Pfizer has asked the FDA to remove a black box – the agency’s strongest warning – from its anti-smoking drug Chantix. The bold-letter warning alerts users of the risk of suicidal ideation as a side effect of using this medication. If you’re dead you can’t smoke anymore, but that’s not how the drug is supposed to work. Moreover, FDA staff scientists say that both studies sponsored by the company as well as outside research present “evidence of insufficient quality to either rule in or rule out increased risk of suicide.”

In response to this, Pfizer released a statement pointing out that the FDA has added some of the results of those very same studies to the aforementioned warning. According to the company, these studies show that there is no difference in serious neuropsychiatric events between patients who take Chantix and other smoking cessation aids. The FDA said that these analyses failed to cover the entire spectrum of neuropsychiatric adverse events linked to Chantix’s active ingredient varenicline, as well as underestimated the actual prevalence of said adverse effects. If that weren’t enough, the agency has been advised by five public safety advocacy groups to not only keep the black box but also expand it to include warnings about convulsions and other issues reported in some users of the drug.

The FDA has received reports of suicide, agitation, hostility, and depression related to Chantix from 2007 to the present day – 105 reports about psychiatric adverse events associated with Chantix were filed to the agency between January 2013 and June 2014. The drug, which cost Pfizer $273 million to settle about 80% of 2,500 lawsuits in 2012 alone, earned the dubious honor of bearing the black box warning in 2009. The company was required by the FDA to perform an encompassing study comparing the psychiatric effects of Chantix with those of ibupropion – another popular quit-smoking drug. The results of that study might play a part in the decision but they are not expected for another year.

Even so, it has been reported that a panel of the agency’s staff and experts will vote on whether or not to remove the black box from Chantix on October, 16th. However, the FDA is not required to enforce the recommendations of this panel.