Chantix (Champix) Considered Just as Dangerous in Australia


. By Gordon Gibb

Concerns over Chantix side effects, including suicide and aggression, are not limited to the United States. The smoking cessation drug sold as Champix in Australia has lately come under fire for similar reasons.

According to the 8/4/10 edition of the Age in Melbourne, the Therapeutic Goods Administration (TGA), the requisite drug regulator in that country, is concerned over reports of hundreds of Australians considering suicide, 15 of which have reportedly been linked to the medication since 2008.

Since Champix was approved for Australia a little more than two years ago, there have been no fewer than 1,025 reports of adverse reactions to Champix. Among them, 206 "suicide-related events" and 15 actual suicides. Of the latter, 13 of the reported suicides were taking Champix exclusively as part of a smoking cessation attempt, and were not taking any other medication when they took their own lives.

Sixty-seven percent of the total adverse reactions reported to the TGA describe psychiatric symptoms such as depression, agitation, anxiety, altered mood and aggression.

There has emerged a debate in Australia between those who feel such a basket of adverse events warrants the removal of Champix and the TGA, which cites a lack of proof that Champix causes 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," said a spokesperson for the TGA, which has no current plans to limit the availability of Champix in Australia.

"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," said the spokesperson. "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."

That is cold comfort to the mother from Tasmania whose adult son, according to the Age, became distressed on Champix and took his own life last year. For his part Professor Diego De Leo, director of the Institute for Suicide Research and Prevention at Griffith University, said he hoped the TGA would commission independent research on Champix to ensure the risks of maintaining its availability was balanced with the benefits afforded to smokers.

A spokesperson for Pfizer, the manufacturer of Champix (and Chantix in the US), acknowledged in the Age report that Champix could be causing adverse reactions in some patients. "Current evidence does not establish a causal link between Champix and these adverse events, but it cannot rule it out either."

About 9.5 million people, according to the report, are using Chantix / Champix worldwide—including more than a million in Australia.


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