Safety

Chantix (varenicline)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

October 2014

Summary View

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience
  • Trial data from a trial conducted in patients who did not succeed in stopping smoking during prior CHANTIX therapy, or who relapsed after treatment (“re-treatment trial”) and a trial conducted in patients with major depressive disorder added.

17 PATIENT COUNSELING INFORMATION

Initiate Treatment and Continue to Attempt to Quit if Lapse

  • section added...Encourage patients who are motivated to quit and who did not succeed in stopping smoking during prior CHANTIX therapy for reasons other than intolerability due to adverse events, or who relapsed after treatment to make another attempt with CHANTIX once factors contributing to the failed attempt have been identified and addressed [see Dosage and Administration (2.1), Clinical Studies (14.7)].

MEDICATION GUIDE

General information about CHANTIX

  • Paragraph added...If you are motivated to quit smoking and did not succeed during prior CHANTIX treatment for reasons other than side effects, or if you returned to smoking after treatment, speak with your doctor about whether another course of CHANTIX therapy may be right for you. 

 

September 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.1 Neuropsychiatric Symptoms and Suicidality
  • extensive changes; see PI for details
5.2 Seizures
  • During clinical trials and the post-marketing experience, there have been reports of seizures in patients treated with CHANTIX. Some patients had no history of seizures, whereas others had a history of seizure disorder that was remote or well-controlled. In most cases, the seizure occurred within the first month of therapy. Weigh this potential risk .....
5.3 Interaction with Alcohol
  • There have been post-marketing reports of patients experiencing increased intoxicating effects of alcohol while taking CHANTIX. Some cases described unusual and sometimes aggressive behavior, and were often accompanied by amnesia for the events. Advise patients to reduce the amount of alcohol they consume while taking CHANTIX until they know whether CHANTIX affects their tolerance for alcohol [see Adverse Reactions (6.2)].

6 ADVERSE REACTIONS

The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling:

ADDED .....

  • Seizures [see Warnings and Precautions (5.2)]
  • Interaction with Alcohol [see Warnings and Precautions (5.3)]
6.2 Postmarketing Experience
  • There have been post-marketing reports of new or worsening seizures in patients treated with CHANTIX [see Warnings and Precautions (5.2)].
  • There have been post-marketing reports of patients experiencing increased intoxicating effects of alcohol while taking CHANTIX. Some reported neuropsychiatric events, including unusual and sometimes aggressive behavior [see Warnings and Precautions (5.1) and (5.3)].

17 PATIENT COUNSELING INFORMATION

17.10 Seizures
  • Encourage patients to report any history of seizures or other factors that can lower seizure threshold. Instruct patients to discontinue CHANTIX and contact a healthcare provider immediately if they experience a seizure while on treatment [see Warnings and Precautions (5.2)].
17.11 Interaction with Alcohol
  • Advise patients to reduce the amount of alcohol they consume while taking CHANTIX until they know whether CHANTIX affects their tolerance for alcohol [see Warnings and Precautions (5.3), Adverse Reactions (6.2)].
17.12 Driving or Operating Machinery
  • Advise patients to use caution driving or operating machinery until they know how quitting smoking and/or varenicline may affect them [see Warnings and Precautions (5.4)].
17.14 Angioedema
  • Inform patients that there have been reports of angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue CHANTIX and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.6), and Adverse Reactions (6.2)].
17.15 Serious Skin Reactions
  • Inform patients that serious skin reactions, such as Stevens-Johnson Syndrome and erythema multiforme, were reported by some patients taking CHANTIX. Advise patients to stop taking CHANTIX at the first sign of rash with mucosal lesions or skin reaction and contact a healthcare provider immediately [see Warnings and Precautions (5.7), and Adverse Reactions (6.2)].

MEDICATION GUIDE

Note: multiple changes including content, format and organizational changes to this document. See PI for specific details.

 

December 2010

Summary View 

ADVERSE REACTIONS

Postmarketing Experience
  • There have been reports of myocardial infarction (MI) and cerebrovascular accident (CVA) including ischemic and hemorrhagic events in patients taking Chantix

Page Last Updated: 11/17/2014
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