On December 10, 2007, the Therapeutic Goods Administration (TGA) in Australia placed new warnings on Chantix (sold as Champix in Australia) after reviewing reports and information received from the U.S. Food and Drug Administration (FDA) concerning the non-nicotine prescription medication specifically developed to help adults quit smoking.

Chantix works by stimulating the same brain receptors as nicotine. The drug provides an aid to cravings and withdrawal symptoms associated with nicotine withdrawal.

On November 20, 2007, the FDA released new information in the U.S. for patients taking Chantix. The agency received reports of suicidal thoughts as well as aggressive and erratic behavior in Chantix patients including the reported death of one patient.

Chantix, which is manufactured by Pfizer, will be sold in Australia beginning January 1, 2008. Under the Pharmaceutical Benefits Scheme (PBS), smokers in Australia will be able to receive one three-month treatment during the course of a year.

Upon reviewing of the same information submitted to the U.S. Food and Drug Administration, TGA of Australia implemented the following safety precautions:

Pfizer was ordered to issue “Dear Doctor” letters in Australia; Product information in Australia was amended to include the same post-marketing information as in the U.S. prescribing information; and New warnings for Australia’s Champix include links to suicidal thoughts, depressed mood, agitation, changes in behavior, suicidal ideation, and suicide.

Since it has not been established whether the drug itself or nicotine deprivation is the cause of suicidality and neuropsychiatric events, a spokeswoman said that “the TGA will continue to monitor the situation.” The FDA has not taken similar action in the U.S.

Source: “Anti-smoking pill carries warning,”(Australia) Daily Telegraph, December 10, 2007.