Julia Medew
August 4, 2010 - 3:00AM
HUNDREDS of people have considered killing themselves while taking the popular quit-smoking pill Champix and another 15 have committed suicide on the medication since 2008, statistics from Australia's drug regulator reveal.
In an update recently sent to doctors, the Therapeutic Goods Administration said 206 ''suicide-related events'' and 15 suicides had been linked to the drug, which has been prescribed more than a million times since becoming available on the Pharmaceutical Benefits Scheme 2½ years ago.
The TGA has also received 1025 reports of suspected adverse reactions to the drug, 67 per cent of which describe psychiatric symptoms such as depression, agitation, anxiety, altered mood and aggression.
A spokeswoman for the TGA said that of the 15 suicides, 13 people were taking Champix and no other medication at the time of their death.
Despite calls for Champix to be banned, the TGA had no plans to limit its availability because there was no proof the drug was causing suicidal thoughts.
''Stopping smoking - with or without medication - may be associated with various psychiatric symptoms such as depressed mood [including suicidal ideation], irritability, anxiety and frustration, or anger; stopping smoking may also exacerbate any underlying psychiatric condition,'' the spokeswoman said.
She said a written warning added to the medication last year for prescribers and consumers detailing the potential side effects was sufficient to protect the public. It also mirrored the approach of drug regulators overseas.
''There is significant information in the product and consumer information for varenicline [Champix] on the association between varenicline use and the development of suicidal ideation,'' she said.
''All medicines have potential risks. The TGA, as a regulator, has to consider the balance between the benefits offered by any medicine and the potential risks associated with its use. These risks and benefits also need to be considered when the medicine is prescribed.''
The drug's manufacturer, Pfizer, says it works by blocking the effect of nicotine on the brain. Last year, a Tasmanian mother called for the drug to be banned after her adult son became distressed on the drug and took his own life. She could not be contacted yesterday.
The director of the Institute for Suicide Research and Prevention at Griffith University, Diego De Leo, said he hoped the TGA would commission independent research on the drug to ensure the risks of keeping it available were balanced with the benefits it offered smokers.
Professor De Leo said it was difficult to establish the cause of suicidality in people taking the drug because many factors could contribute to their feelings, including life events, mental illness and other medications.
Quit executive director Fiona Sharkie said the report would not change Quit's advice to smokers: to discuss with their doctor whether the drug was appropriate for them. Quit does not advocate any one way of giving up smoking.
A Pfizer spokesman acknowledged the drug could be causing adverse events for people.
''Current evidence does not establish a causal link between Champix and these adverse events, but it cannot rule it out either,'' she said.
For help call Suicide Helpline Victoria on 1300 651 251, Lifeline on 131 114, or the Suicide Call Back Service on 1300 659 467.
This story was found at: http://www.theage.com.au/national/quitsmoking-drug-linked-to-suicides-20100803-115hf.html
No comments:
Post a Comment