The Queensland Coroner’s Court considers the possible link between anti-smoking drug Champix and the suicide of a young man.
The Queensland coroner is considering the suicide of 22-year-old Timothy John and the possible neuropsychiatric link with the anti-smoking drug, Champix. As part of the investigation the coroner undertook a review of all suicides in Australia where the person had taken Champix.
Four days after Timothy began taking the drug his mother said that he began acting strangely, asking her to tape up his bedroom door because he thought people were out to get him. The next night Timothy’s mother found him sitting in his room with an electric chainsaw plugged in. Timothy had a pre-existing anxiety disorder, but his mother considered his behaviour to be completely outside what she would normally expect from her son.
Eight days after he began treatment, Timothy took his own life.
The following issues were considered by the coroner:
- The identity of the deceased, when, where and how he died and what caused the death.
- The adequacy of the product labelling and instructions provided with Champix in relation to potential adverse neuropsychological effects.
- The adequacy of the care provided by the deceased's General Practitioner when prescribing Champix in the circumstances.
- Whether any recommendations can be made to reduce the likelihood of deaths occurring in similar circumstances or otherwise contribute to public health and safety or the administration of justice.
In 2009 the United States Food and Drug Administration (FDA) implemented so-called “black box” warnings on all Champix packets (Chantix in the US) in response to a number of incidents, and in 2013 Pfizer (owner and manufacturer of Chantix) paid almost $US300 million to settle thousands of lawsuits filed by plaintiffs in the US alleging that they experienced adverse neuropsychiatric effects whilst on Chantix.
Subsequently, the FDA asked Pfizer to conduct a clinical trial to assess the neuropsychiatric safety of Chantix. The results, which were published in April 2016, indicated that there was no significant increase in the incidence of serious neuropsychiatric adverse events with Chantix compared to placebo and nicotine patches.
Based on the results of that study in September this year a majority of the FDA Advisory committee voted that the black box label should be removed (though the FDA has not yet decided whether to do so).
In Australia the Therapeutic Goods Administration (TGA) does not require a ‘black box’ warning. Champix in Australia also does not contain consumer medical information inside the box, it has to be accessed online. Coroner Hutton expressed concern about that at the inquest, noting:
"When I get my drugs I don't go to the computer and start looking up the drugs, I rely on the manufacturer to put the updated version of warnings in the box,"
The effects of Champix have previously been considered in other Australian States. On 9 December 2015 the Coroner’s Court of Victoria published its Finding Without Inquest into the Death of Benjamin David Johnson, who had committed suicide after taking Champix in February 2015. Coroner Hawkins found that:
“…there is some evidence linking the consumption of varenicline [Champix] with adverse psychiatric symptoms including suicidal ideation or behaviour, however, to date, studies have failed to establish a causal link… the evidence supports that Mr Johnson’s death was an adverse reaction to [Champix].”
As a result of Mr Johnston’s death and two other coronial investigations, the Victorian Institute of Forensic Medicine commenced testing Champix as part of their routine toxicological analyses to assist with enhancing the evidentiary basis of the potential link between Champix and suicide.
A date is yet to be set for the Queensland Coroner’s findings to be handed down.