No-smoke pill linked to psychotic behaviour

THOUSANDS of smokers taking Australia's new anti-addiction pill Champix in the United States have reported psychotic and suicidal behaviour.

The tablet, which curbs nicotine cravings, has been available in Australia since January but label warnings were strengthened one month later after reports from the US and the UK linked it to depression and suicide.

New research released today again links the pill to problems, showing 3000 reports of adverse events including suicides, cardiovascular problems, diabetes and seizures have been reported to the US Food and Drug Administration.

The drug, marketed as Chantix in the US, was linked to 988 serious injuries in those taking the drug in the United States in the fourth quarter of 2007, more than any other product available on the market.

"These data provide a strong signal that the risks of Chantix treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers," say the authors from the Institute for Safe Medication Practices.

Among the reports were 28 suicides, 41 cases of homicidal thinking, 224 reports of heart trouble, 525 reports of hostility or aggression, and 397 cases of possible psychosis.

Consultant pharmacist Dr Geraldine Moses said cases of serious psychological effects had been seen by Australian pharmacists, although not on the same scale.

"It's very, very important that people understand the adverse effects medicine can have on them and know when to report these problems."

But Champix manufacturer Pfizer said the report had limitations as it was based solely on reporting of spontaneous adverse events.

"It is very difficult to establish whether a drug has caused an adverse event based on post-marketing reports," an Australian spokeswoman said.

She said the drug's product information already contained warnings on the operating of heavy machinery and driving.

"It is important for healthcare professionals to discuss benefits and potential adverse events with their patients before initiating treatment."

Champix has been used by over six million smokers worldwide since it was launched in the US in 2006.

The medication is on the Pharmaceutical Benefits Scheme and the Federal Government estimates 194,700 Australians will take advantage of the subsidised rate in 2008.

The pill, which blocks nicotine receptors in the brain, has support from anti-smoking lobby groups as a new hope for weaning smokers off their habit.

The Therapeutic Goods Administration says it is monitoring the situation.