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Published on 22 January 2008

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ADRs prompt varenicline labelling update

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Product labelling for the stop-smoking drug varenicline (Champix®) is to be updated in the USA following neuropsychiatirc 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.

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.

EMEA statement



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