A new anti-addiction pill that curtails nicotine cravings has been linked to increasing psychotic and suicidal behaviour among smokers.
The no smoke pill known as Champix has been available in Australia since January.
A new research showed that 3000 reports of adverse events including suicides, cardiovascular problems, diabetes and seizures.
The drug, marketed as Chantix in the US has been blamed for 988 serious injuries in those taking the drug in the United States in the fourth quarter of 2007.
"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," News.com.au quoted the authors from the Institute for Safe Medication Practices, as saying.
The data released showed 28 suicides, 41 cases of homicidal thinking, 224 reports of heart trouble, 525 reports of hostility or aggression, and 397 cases of possible psychosis.
"It's very, very important that people understand the adverse effects medicine can have on them and know when to report these problems," said consultant pharmacist Dr Geraldine Moses.
However, 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," said an Australian spokeswoman.
"It is important for healthcare professionals to discuss benefits and potential adverse events with their patients before initiating treatment," she added.