Label Changes for:

Chantix (varenicline) tablets

October 2009

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

 

July 2011


5 WARNINGS AND PRECAUTIONS

5.4 Cardiovascular Events
  • In a controlled clinical trial of CHANTIX administered to patients with stable cardiovascular disease, with approximately 350 patients per treatment arm, certain cardiovascular events  .....

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Table 1 title modified

  • CHANTIX has also been studied in a trial conducted in patients with stable cardiovascular disease, a trial conducted in patients with chronic obstructive pulmonary disease (COPD) and a trial conducted in generally healthy patients (similar to those in the premarketing studies) in which .....

17 PATIENT COUNSELING INFORMATION

17.1 Initiate Treatment and Continue to Attempt to Quit if Lapse
  • ...Alternatively, the patient can begin CHANTIX dosing and then set a date to quit smoking between days 8 and 35 of treatment. Encourage...
17.12 Patients with Cardiovascular Disease
  • Patients with cardiovascular disease should be instructed to notify their health care providers of symptoms of new or worsening cardiovascular events and to seek .....

MEDICATION GUIDE

What should I tell my doctor...
  • added...have heart or blood vessel problems
How should I take Chantix?
  • first bullet, number 2....added...You can also start taking CHANTIX before you choose a quit date. Pick a date to quit     smoking that is between days 8 and 35 of treatment. Make sure that you ...
What are the possible side effects....
  • first two bullets modifed or added

 

October 2009

 

REMS

The REMS consists of a Medication Guide
  • Since Chantix (varenicline) was approved on May 10, 2006, we have become aware of postmarketing reports of neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, and suicidal thoughts or actions associated with Chantix (varenicline). This information was not available when Chantix (varenicline) was granted marketing authorization as an aid to smoking cessation treatment. We consider this information to be “new safety information” as defined in FDAAA.

 

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