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U.S. Department of Health and Human Services

Safety

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Chantix (varenicline) Tablets 0.5 mg and 1 mg

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012

 

Summary View

WARNINGS AND PRECAUTIONS

5.4 Cardiovascular Events
  • During non-treatment follow up to 52 weeks, serious cardiovascular events included nonfatal myocardial infarction (3 vs. 2), need for coronary revascularization (7 vs. 2), hospitalization for angina pectoris (6 vs. 4), transient ischemic attack (1 vs. 0), new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (5 vs. 2)

ADVERSE REACTIONS

6.1 Clinical Trials Experience
  • During non-treatment follow up to 52 weeks, the adjudicated events included, need for coronary revascularization (2.0% vs. 0.6%), hospitalization for angina pectoris (1.7% vs. 1.1%), and new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (1.4% vs. 0.6%)