This post was originally written in 2008. We do not know of any active Chantix suicide lawsuits that are pending in 2019. Ultimately, Pfizer paid almost $300 million to settle thousands of lawsuits alleging adverse neuropsychiatric effects from Chantix. The average settlement value of the Chantix lawsuits were not high. But some suicide cases were seven-figure settlements.
In 2016, there was a study done that was published in Lancet that concluded that Chantix did not cause suicidal ideations or actions. Some defense lawyers have argued this is an example of litigation that should not have settled because the science was unclear. But others have pushed back, arguing that the Lancet study (called the EAGLES study) was scientifically unsound.
This is a complex issue. I suspect Chantix has saved lives. I don’t think there was ever a good argument to take the product off the market. (Cf. I may have suggested the possibility below in 2008.) But if there is a concern about the drug, should the manufacturer provide the facts surrounding that concern so doctors and patients can decide for themselves?
- 2019 update on the Chantix litigation
2008 Original Post
When Chantix was introduced into the marketplace to cure nicotine addiction, many saw a panacea that would finally cure our country’s unproductive addiction to nicotine. The problem is that anytime you have a drug that can make a great impact on many people, there is an awful lot of money to be made. As a result, products get rushed onto the market. Did this happen with Chantix? The early returns appear to say yes.
The Food and Drug Administration has received information about numerous serious problems with Chantix, including suicidal thoughts and ideation, homicidal ideations, and hallucinations. The FDA received reports of 37 suicides and 491 cases in which people had suicidal thoughts. If history is any guide, the actual incidences are often more than 10 times what the FDA reports. In other words, these numbers are probably just the tip of the iceberg. Still, there is no indication from Pfizer that there will be a recall of Chantix.
Pfizer released the drug without any warning regarding these potential side effects. By January of 2008, the reports of psychological side effects, most notably suicidal actions, and ideations, reached a critical mass and Pfizer added a warning to the label of Chantix about the potential risks of suicidal behavior and depression. This warning followed a November 2007 update to Chantix’s “post-marketing experience” section which stated that there had been reports of depression, agitation, and suicidal behavior and ideation in patients on Chantix. The FDA now says it is “increasingly likely” that there is an association between Chantix and suicidal thoughts, actual suicide, depression and other psychiatric symptoms.
No one knows exactly how Chantix works. But doctors do have a theory that certainly makes sense. People get addicted to nicotine because the brain craves it. Chantix does a pretty fascinating thing: it targets receptors in the brain that respond to nicotine. By targeting the brain receptors that respond to nicotine and release dopamine, Chantix prevents nicotine from reaching those brain receptors.
Accordingly, Chantix works in two ways. It blocks nicotine from stimulating these brain receptors, so cigarettes do not give users the dopamine release they crave, and it stimulates the release of lower levels of dopamine to help decrease the craving for nicotine which is what drives people who are trying to quit smoking back to cigarettes. And by all accounts, Chantix works for a large number of people who have tried it. In a study published in the Journal of the American Medical Association, 44% of people taking Chantix were able to quit smoking in comparison to 17.7% percent of those taking placebos. No one can argue that Chantix is not an effective drug. But is it safe?
I’m a lawyer, not a pharmacologist. But it does not take a pharmacologist to realize that when you play with the chemicals in the brain that alters mood, like serotonin or dopamine, you are playing with fire. Because no one understands how all of these chemicals work together, altering the brain’s chemical processes should be done with a lot of care and you have to advise patients of the risks associated with doing so. Moreover, everyone’s brain chemistry is different and not every drug is going to suit every person. This is true with any drug, Chantix is no different. But when the side effects are as serious as these appear to be, particularly the suicide, it raises whether Chantix should be on the market at all.