Tony
12-20-2007, 07:47 AM
A WOMAN hospitalised and suicidal after taking a new quit-smoking drug says she wants to caution others of the possible effects.
Brigitte Hordern was prescribed Champix to help her stop smoking.
Because she has bipolar disorder, which she said is well controlled, she sought advice before joining the limited Australian roll-out.
"There are risks with any drug, but I'm a severe asthmatic and have tried several times to give up smoking," said Ms Hordern, of Glenorchy.
"I kept a mood diary and in the first week after starting it I had more depression, I felt agitated and got vengeful thoughts.
"A few days later I was threatening to kill people. I took an overdose of my bipolar medication, my partner called an ambulance and the police came because I was so aggressive," Ms Hordern said. "I was taken to psychiatric intensive care and was sedated and kept in an isolation room for two days. I've been told there are other cases with a similar reaction."
The US Food and Drug Administration is reviewing the drug after concerns over suicidal thoughts, and behaviour and aggression.
Australia's drug regulator, the Therapeutic Drugs Administration, said it was reviewing the data.
A letter has been sent to Australian doctors involved in the "product familiarisation" program -- which Ms Hordern was part of -- informing them of changes to US prescribing information.
Champix will soon be covered by the Pharmaceutical Benefits Scheme.
Pfizer said trials of 5000 Champix patients did not show a difference in aggression, changes in mood, suicidal thoughts or suicide between Champix and taking a placebo. It said stopping smoking with or without medical treatment was associated with nicotine withdrawal symptoms which could include a depressed mood.
The product information already contained precautions relating to worsening of underlying psychiatric disease and development of psychological symptoms.
The Consumer Medicine Information service advised patients with a history of mental illness to discuss this with their doctor before taking Champix.
Brigitte Hordern was prescribed Champix to help her stop smoking.
Because she has bipolar disorder, which she said is well controlled, she sought advice before joining the limited Australian roll-out.
"There are risks with any drug, but I'm a severe asthmatic and have tried several times to give up smoking," said Ms Hordern, of Glenorchy.
"I kept a mood diary and in the first week after starting it I had more depression, I felt agitated and got vengeful thoughts.
"A few days later I was threatening to kill people. I took an overdose of my bipolar medication, my partner called an ambulance and the police came because I was so aggressive," Ms Hordern said. "I was taken to psychiatric intensive care and was sedated and kept in an isolation room for two days. I've been told there are other cases with a similar reaction."
The US Food and Drug Administration is reviewing the drug after concerns over suicidal thoughts, and behaviour and aggression.
Australia's drug regulator, the Therapeutic Drugs Administration, said it was reviewing the data.
A letter has been sent to Australian doctors involved in the "product familiarisation" program -- which Ms Hordern was part of -- informing them of changes to US prescribing information.
Champix will soon be covered by the Pharmaceutical Benefits Scheme.
Pfizer said trials of 5000 Champix patients did not show a difference in aggression, changes in mood, suicidal thoughts or suicide between Champix and taking a placebo. It said stopping smoking with or without medical treatment was associated with nicotine withdrawal symptoms which could include a depressed mood.
The product information already contained precautions relating to worsening of underlying psychiatric disease and development of psychological symptoms.
The Consumer Medicine Information service advised patients with a history of mental illness to discuss this with their doctor before taking Champix.