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Varenicline Warning

According to a Food and Drug Administration early communication, postmarketing studies have revealed that varenicline (Chantix) may increase the risk of drowsiness, aggressive and erratic behavior, suicidal thoughts, and possible suicide attempts.
   The magnitude of varenicline’s role in adverse behavioral effects isn’t yet clear because nicotine withdrawal itself may worsen underlying psychiatric illness. However, early analysis suggests that varenicline may foster a depressed mood, suicidal ideation, and changes in emotion and behavior during the early days and weeks of treatment. Until more study details emerge, FDA officials make these recommendations:

  • Monitor patients taking varenicline for behavior and mood changes.
  • Tell patients to contact their prescriber if they have behavior or mood changes.
  • Explain that varenicline may cause drowsiness, and urge caution when driving a car or performing other hazardous activities.
   Varenicline is approved as an aid to smoking cessation. It binds with specific neuronal nicotinic acetylcholine receptors, preventing nicotine from binding to these receptors.


     
   

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