Australia's drug modulator has revealed 15 people have committed suicide and hundreds have experienced suicidal thoughts while on Champix - the popular smoking-cessation drug, since 2008.
The drug which was made available to the public - listed on the Pharmaceutical Benefits Scheme - from the previous two and half years, has been prescribed more than a million times.
The Therapeutic Goods Administration (TGA) sheds the light on the extremely disturbing statistics that about 206 suicide-related cases and 15 suicides are connected to the use of the drug.
A staggering number of 1,025 reports of suspected adverse reactions to Champix has reached the TGA and a total of 67 per cent of cases are related to psychiatric symptoms such an agitation, altered mood, anxiety, depression and aggression.
Of the 15 suicides, the TGA's spokeswoman revealed that 13 people were on Champix and not on any other medication at the time of their death.
The plans to ban Champix were never taken seriously, by the TGA as there was no concrete fact that the suicidal deaths were the direct result from taking the quit-smoking pill.
It has been known that quitting smoking with or without the help of a medication may be related to a list of psychiatric symptoms.
The spokeswoman said, 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.
According to her, the written warning that was attached to the medication just last year was suffice to provide prescribers and consumers the knowledge of its potential side effects, safe enough for the public.
She said the TGA as a drug modulator has to look at the balance between the drug benefits and potential risks related to its usage.
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.
An independent research to assess the risks the drug present as well as the benefits it carries is something that the TGA is hoped to commission, said Diego De Leo of the Griffith University.
Spokesman of Pfizer recognized the drug could be dangerous for people. While Fiona Sharkie of Quit advised people to consult with their doctor if the drug is safe for them to use. She said the current data does not conclusively establish a causal link between Champix and the adverse health implications