New Warnings on Chantix®
In June 2011, the FDA forced manufacturer, Pfizer, to change the warning labels on Chantix® to more strongly indicate and warn of the enhanced risks of cardiovascular disease. Pfizer and the FDA also created new and additional prescribing information for medical providers. See FDA Safety Announcement at http://www.fda.gov/Drugs/Drugsafety/ucm259161.htm
The new label must warn of the enhanced risks of angina pectoris (chest pain caused by reduced blood flow to the heart muscle), non-fatal or fatal myocardial infarction (heart attack, leading to death or not), undergoing coronary revascularization (coronary artery bypass surgery), peripheral vascular disease (PVD) (narrowed arteries reduce blood flow to your limbs), peripheral arterial disease (PAD) (narrowed arteries reduce blood flow to your limbs) and death.
In July 2009, the FDA required Pfizer to add a “black box” warning to its Chantix® label. The agency also ordered Pfizer to publish a Medication Guide, which described risks like Chantix® suicide, to be distributed to every patient taking the drug. The new warning included enhanced wording regarding severe depression and suicide.
Chantix® has not yet been issued an FDA recall.