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Thoughts and Acts of Aggression/Violence Toward Others Reported in Association with Varenicline(September) (FREE) 

OBJECTIVE: To identify the common characteristics of these thoughts and acts of aggression/violence toward others and assess the likely relationship to varenicline treatment.

METHODS: We obtained 78 adverse event reports from the Food and Drug Administration MedWatch database . . .

CONCLUSIONS: The clear temporal relationship, lack of prior history of this behavior, and unusual nature of these events strengthens the accumulating scientific evidence that varenicline is associated with thoughts and acts of aggression/violence. We recommend that physicians and pharmacists ensure that all patients are informed of possible psychiatric symptoms of varenicline, including violent and aggressive thoughts. All patients should be advised to contact a health-care provider immediately if these symptoms occur and varenicline should be discontinued without delay.

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