US FDA Drug Safety Communication: Varenicline (Chantix) label to be updated to include potential alcohol interaction, rare risk of seizures, and neuropsychiatric adverse effects

The FDA advises a labelling change for varenicline to include an increased risk of seizures, a reduced tolerance to alcohol, and increased incidence of neuropsychiatric adverse effects such as agitation, aggressive behaviour, depressed mood, or development of suicidal ideation.

This FDA Safety Update follows a review of case series submitted by Pfizer, as well as a review of cases in the FDA Adverse Event Reporting System (FAERS) database.

 

 

The MHRA has previously issued a Drug Safety Update for varenicline in 2009 advising no clear evidence that varenicline was associated with an increased risk of fatal or non-fatal self-harm.