Smokers prescribed Champix to help give up the habit are being given stronger warnings about the risks of psychiatric symptoms.
The production information (PI) for varenicline, marketed in Australia as Champix, also now includes a warning that consuming alcohol may increase the risk of psychiatric symptoms.
The Therapeutic Goods Administration (TGA) on Wednesday issued an advisory for consumers and health professionals saying the PI has been updated with new safety information.
"Psychiatric symptoms can involve changes in behaviour, thinking or mood and may include depression, anxiety, agitation, aggression, mood swings, self-harm, thoughts of self-harm, or seeing, hearing or sensing things that are not there," the advisory said.
Varenicline helps reduce nicotine cravings and withdrawal symptoms.
The updated PI is aimed at increasing awareness that serious psychiatric symptoms have been reported in patients taking the drug.
It also is stressing the importance of stopping treatment with varenicline and immediately contacting a health professional if the symptoms are experienced or observed.
The information was previously in the PI, but is now made more prominent, and the alcohol warning has been added.
The TGA noted other factors can contribute to psychiatric symptoms being reported in relation to treatment with varenicline, including the effects of nicotine withdrawal, existing psychiatric conditions and use of some other medicines.
The updated PI also includes information from clinical trials and observational studies, which found similar incidence rates of common psychiatric symptoms in patients treated with varenicline as to those treated with placebo or alternative treatments.
