The Australia Therapeutic Goods Administration (TGA) advises consumers and health professionals that the Product Information (PI) for varenicline, marketed in Australia as Champix, has recently been updated with new safety information. This information relates to the risks of psychiatric symptoms and potential interaction with alcohol. 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.
Varenicline is a prescription medicine that assists adults to stop smoking by helping to reduce nicotine cravings and withdrawal symptoms. Smoking is associated with serious health problems that can lead to death.
The updated PI aims to:
• increase awareness that serious psychiatric symptoms have been reported in patients taking varenicline
• stress the importance of stopping treatment with varenicline and immediately contacting a health professional if these symptoms are experienced or observed.
The above information was previously provided in the PI, but is now listed in bold text at the beginning of the Precautions section, under the heading 'Psychiatric Symptoms', to reinforce these important messages.
The Precautions, Interactions With Other Medicines and Adverse Effects sections of the PI have also been updated regarding the need to advise patients that consuming alcohol may increase the risk of psychiatric symptoms.
It is noted that there are a number of other factors that can also 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 suicidal thoughts and/or behaviour, as well as other common psychiatric symptoms, in patients treated with varenicline as to those treated with placebo or alternative treatments.
Consumers are advised that if they or someone they care for is taking varenicline, be aware of the risks of psychiatric symptoms and potential interaction with alcohol. If they suspect any psychiatric symptoms, such as depression, anxiety, agitation, aggression, mood swings, self-harm, thoughts of self-harm, or seeing, hearing or sensing things that are not there, during treatment with this medicine, stop taking it and contact a health professional immediately.
Health professionals are advised to be aware of the above information and refer to the PI for further details, and to discuss the benefits and risks of varenicline treatment, including potential interaction with alcohol, with patients who are taking, or for whom they may prescribe, this medicine.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/varenicline-champix
In Hong Kong, there are three registered pharmaceutical products containing varenicline, namely Champix Tab 0.5mg (HK-55479), Champix Tab 1mg (HK-55437), and Champix Tab 0.5mg & 1mg (HK-55462). All these products are prescription-only medicines which are registered by Pfizer Corporation Hong Kong Limited (Pfizer). Related news was previously issued by the US FDA, and was posted on the Drug Office website on 10 March 2015. Letters to inform local healthcare professionals were issued on the same day. So far, the Department of Health has not received any adverse drug reaction case related to varenicline. In light of the new safety findings, Pfizer has submitted an application to include the new warnings in the package insert of the products. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, December 02, 2015
Issued at HKT 13:00
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