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bupropion hydrochloride
Zyban
  Pharmaceutical company:
GlaxoSmithKline
www.gsk.com

NEW WARNING
The Food and Drug Administration (FDA) has required manufacturers of bupropion hydrochloride (Zyban) and varenicline tartrate (Chantix), medications used to aid smoking cessation, to add new boxed warnings and develop patient medication guides to highlight the risk of serious neuropsychiatric symptoms (behavioral changes, hostility, agitation, depression, suicidal thoughts and behavior, and attempted suicide) in patients taking these products. Health care providers should advise patients to stop taking these drugs and notify the prescriber if these symptoms develop. If varenicline or bupropion are stopped because of neuropsychiatric symptoms, the patient should be monitored until symptoms resolve.
   Health care professionals are also advised to:

  • Weigh the risks of developing adverse effects against the benefits of quitting smoking.
  • Discuss the possibility of developing symptoms and the benefits of quitting smoking with the patient before prescribing these medications.
  • Monitor all patients taking these drugs for serious neuropsychiatric symptoms.
  • Monitor patients with serious psychiatric illness (schizophrenia, bipolar disorder, major depressive disorder) for worsening of their pre-existing illness while taking these drugs.
  • Inform patients that they may experience irritability, anxiety, depression, and insomnia while withdrawing from nicotine whether or not they're taking these drugs.

     
   

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