Australia - stronger new warnings for Champix (Chantix)..

August 4, 2010 - Therapeutic Goods Administration (TGA) has sent a fresh alert to doctors to remind them of the potential risks of Champix (Chantix in U.S., generic name - varenicline) problems. In its updated bulletin, the TGA said it received 1025 reports of suspected adverse reactions to Champix between January 2008, when it was added to the Pharmaceutical Benefits Scheme, and May this year.

Fifteen people have committed suicide after taking the anti-smoking drug Champix since January 2008. Another 191 patients have reported suicidal thoughts and related effects. The latest figures suggest a doubling in the numbers of suicides linked to Champix since July last year, when the Therapeutic Goods Administration put the tally at six.

Two-thirds, or 691 of these, described "psychiatric symptoms such as depression, agitation, anxiety, altered mood and aggression" after taking the drug, also known by its chemical name of varenicline, the bulletin said.

Use of the drug as a smoking cessation aid is accelerating. There were 250,000 PBS scripts for Champix issued to August last year -- a figure that has soared to more than one million since then.

Champix has long been dogged by reports of suicidal thoughts and its information leaflets warn of the risks. Last year, U.S. regulators ordered these warnings to be strengthened.

A TGA spokeswoman said it was not possible to say Champix caused the suicidal effects, as nicotine withdrawal itself could trigger similar symptoms.

"In general, overseas agencies have taken a similar approach to the TGA in raising consumer and prescriber awareness," the spokeswoman said.

Reference: Anti-smoking drug suicide toll reaches 15, Adam Cresswell, Health editor, The Australian, 8/4/2010.

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