Product labelling for the stop-smoking drug varenicline (Champix®) is to be updated in the USA following neuropsychiatric adverse effect warnings from the EMEA.
Manufacturer Pfizer said the move was based on FDA and Pfizer ongoing safety reviews of post-marketing reports, which noted adverse events.
↓Article continues below this sponsored advert↓
Explore the latest advances in cardiovascular care delivered by renowned experts from recognised Centres of Excellence and other NHS trusts around the UK. Gain CPD, put your burning questions to the experts, and boost your confidence when it comes to care for your patients.
↑Advertisement↑
Labelling would now include a warning that patients attempting to quit smoking with varenicline should be observed for serious neuropsychiatric symptoms, including changes in behaviour, agitation, depressed mood, suicidal ideation and suicidal behaviour.
The EMEA and the UK’s MHRA previously issued warnings of risks of suicidal ideation and depression in patients taking varenicline.
