Editorial Note: On October 16, there is an FDA hearing about Chantix and violence which is widely expected to feature an effort by Pfizer to roll back the warnings on the drug. One of the fascinating things about the Chantix story has been to see perfectly normal friends who use it to stop smoking become very agitated, and distressed. I don’t personally know anyone who has committed suicide or violence, but I know a lot who say yes they can see how this could happen. And in this case it’s very difficult to see any mental illness that might be causing the problem.
Below are a group of cases from the FDA database sent by Tom Moore of the Institute of Safe Medication Practices (ISMP) who along with Public Citizen and others have lodged a Citizen’s Petition arguing for a strengthening of the warnings – not a weakening. This is an important issue. These warnings have saved lives. We are facing a new onslaught on the ability of either doctors or patients to be able to believe the evidence of their own eyes when it comes to adverse events.
By the third day of taking Chantix I was completely out of control. I woke my boyfriend up in the middle of the night and started physically beating him. I contemplated suicide about 5 times a day and contemplated homicide about 3 times a day.
This case shows early onset prior to smoking cessation, sleep disturbance, homicidal ideation, suicidal ideation, and later but not shown here, attempted suicide. Female, age 24.
She had a nightmare on 23 Dec 2007 that she was lying in prison laying on a cold wet floor shackled to a corpse. On 26 Dec 2007 she wanted to get the key to the gun cabinet and shoot her husband.” She stopped taking Chantix and “everything setting her off resolved on 28 Dec 2007.”
This case shows a sleep disturbance so vivid it approaches a hallucination, and is followed by an apparently unrelated episode of homicidal ideation and dechallenge. Female, age 43.
She swung at her mother (who was in her late 90’s) due to the extreme rage as she almost struck her and missed. She went out in the back yard and broke a weed wacker, a couple of glasses, the frame work on a couple of lamps, she threw concrete in the backyard and she began stabbing chunks of wood with the garden tools to get her rage out.
In this case report reviewed by FDA OSE the index event was suicidal ideation, but the narrative excerpt portrays uncontrolled aggression/anger and senseless violence.
On Saturday while at home she got into a verbal argument with her mom over a minor issue and reports now that she was ‘totally out of hand’ and she was unable to control her impulses and was yelling and screaming and crying. She acutely became suicidal and also became homicidal threatening her mother with a shotgun. Her mother fled the house and called police. She locked herself in the bathroom and eventually calmed down.
Suicidal behavior and senseless aggressive acts occur together. Female, age 21
After 2 weeks of taking Chantix, I flew into a fit of uncontrollable rage after consuming alcohol one evening – resulting in me beating my boyfriend, followed by an attempt to take my own life. An overnight stay in the ER followed.
Senseless aggression and suicide attempt. Symptoms resolved on discontinuation. Female, age 28
Appellant was nineteen years old and had been in the service for approximately a year. Prior to enlisting, Appellant was an active member of his community and led various volunteering and mentoring projects as an Eagle Scout. Upon turning eighteen, both Appellant and his twin brother enlisted in the United States Army. After successfully completing Infantry Training and the Airborne Course, they were both selected for an appointment to the United States Military Academy Preparatory School (USMAPS), class of 2009. [Was temporarily assigned to a supply room at Fort Benning and prescribed Chantix].
Appellant had been experiencing “new and strange thoughts” including a “person [was] telling me . . . dangerous things that arent [sic] me.” These included violent thoughts of killing someone. On May 18, 2008, one month after the Army doctor prescribed Chantix, Appellant fatally attacked Private (PVT) Bulmer while he was sleeping, stabbing him to death. Prior to this attack, Appellant did not know nor had he ever interacted with PVT Bulmer.
This case includes nightmares, psychosis, homicidal ideation, senseless act, and homicide. Male, age 19. Extracted from appeals court judgment reversing his murder conviction because the judge did not allow a CHANTIX defense of involuntary intoxication.