Champix Update: Could quitting smoking be dangerous for your health?

Inquest Date: 29 September 2016; 21-22 November 2016 (delivered on 14 September 2017)

Coroner: Mr John Hutton

Place: Brisbane

Date of Death: 17 April 2013

Issues for Consideration

  1. The adequacy of the care provided by the deceased’s General Practitioner when prescribing Champix;
  2. The adequacy of the product labelling and instructions provided with Champix in relation to potential adverse neuropsychological effects;
  3. 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.

Factual Summary

On 18 January 2017, we reported on the Queensland Coroner’s Court consideration of the possible link between anti-smoking drug Champix, and the suicide of a young man, Timothy John. At that time, the coroner was yet to hand down any findings.

A link to our previous article is available here.

The Coroner’s Court has now delivered its findings.

Timothy John (aged 22) was prescribed an anti-smoking drug, Champix. Four days after he 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 taking Champix, Timothy took his own life.

Evidence

Evidence of Dr Yang

  • Dr Yang prescribed Champix on 10 April 2013. His consultation notes recorded that Timothy was still suffering severe anxiety but not suicidal. Dr Yang explained that Champix may make his psychiatric symptoms worse and he needs to cease the medication and see a doctor if this occurs.
  • Dr Yang noted that the Champix Product Information on MIMS Online stated that Champix may have some adverse effects on the patient’s mood and behavior, but it did not state that Champix was contraindicated for patients such as Timothy with a history of mental illness.
  • Given Timothy’s history of depression and anxiety, Dr Yang was reluctant to prescribe Champix. He therefore questioned Timothy about his current mental health. Dr Yang ultimately prescribed the drug as Timothy’s mental state appeared stable, and he specifically asked for Champix by name.
  • Dr Yang admitted that he had not read the ‘Psychiatric Symptoms’ section of the Champix Product Information, due to time constraints.
  • Dr Yang was aware of the need for a patient to enter into a comprehensive support or counselling program when prescribing Champix. However, he considered that he had done this by providing advice to Timothy about possible adverse effects of the drug and to cease taking it and see a doctor if he experienced any issues.
  • Dr Yang saw Timothy a week after prescribing Champix for an unrelated issue. Timothy did not raise any issues about his anxiety (including the chainsaw incident). Dr Yang did not enquire about his use of Champix and relied on Timothy to tell him how he was doing.

Evidence of Timothy’s mother

  • Following the prescription for Champix, Timothy told his mother that Dr Yang could see that Timothy had PTSD and anxiety and that the medication might increase his anxiety. Timothy and his mother agreed that he was not experiencing anxiety at present and they weren’t too worried about this. Timothy did not tell his mother about the need to stop taking Champix in the event his anxiety increased.
  • On day 5 of taking Champix, Timothy wanted to duct tape his door as he was worried someone might come into his room. His mother did not regard this as strange behavior, as she was used to dealing with his anxiety.
  • On day 6 of taking Champix, Timothy was found in his bedroom with an electric chainsaw sitting in his lap and plugged in. Timothy was worried that people were coming to get him.

Autopsy results

  • Autopsy revealed a therapeutic range of Varenicline (Champix).
  • Timothy’s cause of death was hanging. There were signs of recent abrasions to his left wrist and forearm, which could have been inflicted near the time of death.
  • There was no alcohol or illicit drugs in his system at the time of death.

Conclusions

Did Champix contribute to Timothy’s death?

  • Champix contributed to Timothy’s death, however, it was not possible to determine the level of contribution that Champix had on Timothy’s death due to his pre-existing mental health condition.
  • Champix does in fact increase the risk of suicide in patients with a history of psychiatric disorder, such as Timothy, compared to people attempting to quit smoking without a medical aid (reference was made to the Evaluating Adverse Events in a Global Smoking Cessation Study).
  • Timothy’s history of major depressive disorder and anxiety placed him at higher risk of suicide while taking Champix.
  • It was not until eight days after Timothy commenced the Champix medication that Timothy’s psychological condition deteriorated significantly, to the point that he suicided. Prior to taking Champix, Timothy appeared stable.

Did Dr Yang provide adequate care when prescribing Champix?

  • Dr Yang (the general practitioner who prescribed Champix) did not provide adequate care when prescribing the drug. He did not familiarize himself with the precautions listed. Timothy was not asked about the possibility of family inclusion in his treatment.
  • If Timothy’s family had been informed by Dr Yang (or by warnings on the packaging) about the need to stop taking Champix and contact a doctor immediately if Timothy exhibited neuropsychiatric symptoms, his family would have taken appropriate earlier action. It is possible that Timothy’s death may have been avoided.
  • Dr Yang held concerns about prescribing Champix to Timothy due to his mental health condition and his awareness that this could increase risk, yet he did not put in place a structured follow up plan for Timothy. He instead relied on Timothy to make a follow up appointment, and to identify if he needed to see a doctor.

The adequacy of Champix product labelling

  • Certain aspects of the product labelling and instructions provided with Champix are inadequate, and improvements can be made.

Recommendations

  • Improvements be made to the Champix product labelling, Consumer Medicine Information leaflet and Product Information document. In particular, the packaging should contain an alert about when to immediately cease and see a doctor.
  • The Consumer Medicine Information leaflet should be included within the Champix packaging.
  • The Product Information document should be amended to include practical guidance as to how a medical practitioner should alert and advise the family of a patient about the relevant precautions, and the need to put structured follow up plans in place when prescribing Champix.
  • The general practice community should take note of this case and ensure that before prescribing Champix, they provide direct advice to an appropriate family member/carer, about the need to monitor the patient and cease taking the drug and seek medical help if they exhibit neuropsychiatric symptoms. If the patient is unwilling to consent to such a warning being provided to a third party, the GP should reconsider prescribing the drug.
  • All State and Territory forensic pathology services conduct routine toxicology screening for Varenicline in relation to suicides and suspected suicides.

Chronology of Events

Prior History

Timothy had a long history of drug and alcohol addiction starting at the age of 13. 

In 2006, when Timothy was 15, his family home caught on fire and he lost all his possessions. Timothy may have  attempted suicide (through an overdose of Panadol) in the context of this traumatic event and his unstable depression and anxiety, and alcohol and drug abuse.

In November 2012 he was admitted to Belmont Private Hospital to undertake intensive Cognitive Behaviour Therapy for 3 weeks to address his drug use and long standing anxiety problems. Having completed the program, he had limited his drinking, had quit drugs and cut down on his smoking.

April 2013

03.04.2013

According to his mother, Timothy saw Dr Yang and reported having difficulty giving up smoking.  It is alleged that Dr Yang told Timothy he could prescribe medication but first needed permission (note, that was not recorded in Dr Yang’s notes).

It is noted that Timothy had some success on Nicorette gum and spray, reducing his smoking from 20 cigarettes a day to seven.  However, he had not been able to reduce his smoking to zero and had experienced an episode of fainting while taking the Nicorette spray.

10.04.2013

Dr Yang prescribed Champix. Timothy appeared to be in a stable condition and without suicidal ideation. Dr Yang indicated that the medication may have an adverse effect on his mood and may increase the likelihood of mental illness.

10.04.2013 (3:30pm)

Timothy commenced taking first Champix tablet.

14.04.2013

Timothy commenced taking two tablets of Champix a day.

15.04.2013

Timothy asked if he could tape up his bedroom door as he was concerned that someone might come into his room, and he did not feel safe.

16.04.2013 (5:30pm)

Timothy’s mother received a call from Timothy’s brother, Peter. While Peter was on the phone, Timothy punched a chest of drawers and broke it. Peter told her that Timothy was angry.

The brothers attended their mother’s house for dinner. Later that night, Timothy was found sitting on the floor of his bedroom, with an electric chain saw sitting in his lap and plugged in. Timothy said that people were coming to get him.

Timothy’s mother was reluctant to call an ambulance for fear that strangers might upset him further. She stayed with him through night until he fell asleep.

17.04.2013 (9:00am)

Timothy had a pre-arranged injection appointment (unrelated to the Champix) with Dr Yang.

Timothy’s mother noticed red welts on his left arm and wrist. She did not attend the appointment with Timothy, but was comforted by the fact that Timothy would have to remove his shirt for his injection, and believed this issue would be raised with the doctor.

Dr Yang’s consultation with Timothy was brief, and he did not raise anything about his mental health status. He presented normally, with no signs of stress. There was no discussion of taking Champix.

The nurse who performed the injection did not recall seeing any markings or injuries to Timothy’s arms.

During the drive home, Timothy asked his mother whether he should stop taking the Champix as it was making him feel strange.

17.04.2013 (3:00pm)

Timothy’s mother dropped him and his brother off at their house. Timothy’s brother had an afternoon sleep until around 4:30pm. He woke to find Timothy hanging by an electrical cord under the back patio of their house.

Timothy’s brother phoned 000 and then cut his brother down with a knife. The ambulance arrived around 4:41pm and declared Timothy deceased.