Psychotic Rage: Drug Side-Effect or Detoxification Byproduct?

Recently, the estates of Pennsylvania couple, Sean and Natalie Wain, filed a product liability lawsuit against Pfizer in the United States District Court for the Western District of Pennsylvania. The complaint alleged that the pharmaceutical company’s smoking cessation drug, Chantix, caused Wain to experience psychotic rage, shoot and kill his wife, and commit suicide in May 2009. Allegedly, Wain had been taking the drug for one or two weeks prior to the incident.

This action is only the most recent in a long line of Chantix-related claims. Over 100 lawsuits have been filed against Pfizer alleging that plaintiffs or their decedents committed suicide, suffered severe injury attempting to commit suicide, or exhibited unusual behavior after taking Chantix. Besides the consumption of Chantix, there is only one other apparent similarity among the plaintiffs – they were all deprived of cigarettes.

Being deprived of an addiction is difficult even without the alleged side effects of medication. We here at Abnormal Use know this all too well. No phone messages are checked or emails are read at the office until we get our first taste of coffee in the morning. On those rare occasions when that fresh nectar is not immediately available upon our arrival, we get a little angry. Our indignation only escalates as we await the percolation of our precious drink to relieve us of the perils of our temporary detoxification. While we have never reached the level of “psychotic rage,” we have also never been deprived of coffee for two weeks.

According to a study by the Institute of Safe Medication Practices, Chantix was shown to create violent behavior when users first began taking the drug, often before they had completely stopped smoking. The study also noted that the violent behavior ceased for 93 percent of the participants after they quit taking Chantix.

While this study may appear to be damning for Pfizer, a closer look indicates that it may not be as conclusive as the plaintiffs desire. First, the study was a mere compilation of Chantix adverse event reports submitted to the FDA. By limiting itself to the 78 reports submitted to the FDA and not examining the thousands of other Chantix users, the study lacks the ability to paint a global picture of the drug’s side effects. Second, this was not a controlled research study. The Institute did not gather a representative sample of individuals who wished to quit smoking. They did not study the individuals prior to the consumption of the drug. They did not administer any placebos. This study is far from what one would expect of viable scientific research.Without a controlled environment, the study lacked the ability to factor in third variables. By examining only cases reported to the FDA, at best, the study reveals correlation – not causation. With these limititations, suggesting that it is Chantix, not the process of quitting smoking, which is causing these side effects is premature.

We do not mean to suggest that these plaintiffs did not display violent behavior after taking Chantix. Nor do we suggest that quitting smoking always leads to psychotic rage. Rather, we suggest that we withhold judgment of Pfizer and Chantix before making sure that no other factors are at play. Of course, if making rash conclusions is your addiction, we know how withholding judgment may make you feel.