Chantix, the drug aimed at assisting smokers who want to end their addiction, has been mired in controversy since Pfizer first began selling the drug. First, stories about bizarre behavior began leaking out to the press. One journalist back in 2008 even wrote a first person experiential essay about how his brain felt on Chantix. He detailed lucid nightmares and his slow but steady descent into madness – until his eventual breakdown and cessation of the drug. Over 2,500 lawsuits have been filed – and roughly $300 million has already been paid to people negatively affected by the drug.

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Henry Fuseli’s “The Nightmare” depicts sleep paralysis through a demonic nighttime visitor.

Now, Pfizer has asked the FDA to remove the black box warning which states that users may be at an increased risk of suicide and violent thoughts. The hearing was last week, Thursday, October 16th 2014. FDA staff recommended that the label actually be strengthened rather than weakened in light of Pfizer’s supposedly positive clinical results. The FDA panel decided to keep the black box warning about suicide risks on Chantix. Of 18 voting members, 11 voted that the warning should be retained until the outcome of a new prospective study come out next year. Six of the eleven panel members said that the black box warning label should actually be strengthened. There was only one vote on the panel to remove the warning entirely.

A recent study produced by Pfizer has been criticized by FDA staff for being too narrowly constructed, which may have skewed results in a more positive direction. According to a briefing document produced by FDA staff, the studies were limited by an “incomplete ascertainment of outcomes” in their observations. In many cases, researchers for Pfizer relied on certain diagnostic codes that may not fit the observed psychiatric effects of the drug. Many psychiatric adverse events, in other words, were likely missed by the study.

Five non-profit groups are pushing for an enhanced black box warning on Chantix. These are consumer watchdog groups like Consumer Reports, Institute for Safe Medication Practices, National Center for Health Research, National Physicians Alliance, and Public Citizen. Several government agencies in charge of regulating certain industries have also banned or limited the use of Chantix by specific types of employees. For example, airline pilots are banned from taking Chantix by the Federal Aviation Administration, and the Department of Transportation has limited the use of the drug by truck drivers, for safety reasons. The Department of Defense has also banned the use of Chantix by its aircraft and missile crews.

These groups have banned use of the drug by their employees for good reason – a high profile case in 2007 highlights the drug’s dangers. A musician by the name of Carter Albrecht went on a spree of violence after a few cocktails and a week on the drug – harming his girlfriend both emotionally and physically in the process. His girlfriend said that he was acting as if he was in a nightmare. Just a few weeks later, Albrecht was killed by gunshot on a peaceful street in Dallas after a neighbor found him trying to enter into a stranger’s home. He was shot in the head.

Is it worth taking Chantix? That’s a question only you and your doctor can answer together. Thankfully, you’ll both still be informed by Chantix’s label about what kinds of psychiatric symptoms you may experience.