Since 2007 Natural Health News has been covering Chantix (Champix). Today a new report show continuing risk with the drug.
FDA Warns of MI, PAD Risk With Chantix
By Peggy Peck, Executive Editor, MedPage Today
Published: June 16, 2011
WASHINGTON -- The FDA warned today that smokers with a history of heart attack or stroke who use the smoking cessation drug varenicline (Chantix) may increase their risk of a second heart attack or new onset peripheral vascular disease.
The agency said an additional warning will be added to the drug's label and prescribing information describing a small, but measurable increase in the risk of cardiovascular events including nonfatal myocardial infarction, angina, and need for coronary revascularization.
Additionally, the label will warn that use of varenicline may increase the risk for a "new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease" among persons with a history of cardiovascular disease.
In its announcement, the FDA noted that smoking significantly increases the risk of cardiovascular events, so it advised physicians and patients to weigh the known benefits of varenicline treatment "against its potential risks when deciding to use the drug in smokers with cardiovascular disease."
The FDA decided to add the warnings after it reviewed data from a randomized, double-blind, placebo-controlled study of 700 smokers with a history of cardiovascular disease who were treated with varenicline or placebo.
The FDA said it was "continuing to evaluate the cardiovascular safety of Chantix" and had ordered the drug's maker to conduct a meta-analysis of data from all varenicline studies as part of an ongoing review of the drug's cardiovascular safety.
Concerns about cardiovascular safety come on top of previous reports of increased risk of suicidal ideation association with varenicline, which is marketed by Pfizer.
Selections from Natural Health News
Feb 01, 2011
The latest January 2011 QuarterWatch (analyzing FDA's MedWatch adverse effect reports for Quarter 2 of 2010) found that despite prominent label warnings, the stop-smoking drug varenicline (CHANTIX) continues to pose ...
Dec 17, 2010
A reader was looking for natural alternatives to Chantix/Champix, so I thought I'd provide some information based on methods I've suggested to people over the years that have been very helpful. I generally suggest that ...
Feb 02, 2008
"We've become increasingly concerned as we've seen there are a number of compelling cases that truly look as if they are the result of exposure to the drug," Bob Rappaport, a director in FDA's unit that oversees Chantix, ...
Jun 18, 2008
Yes, Chantix is associated with a large number of suicides, but what is more devastating is the recruiting of our already abused soldiers to test the drug, and just for thirty pieces of almost worthless paper. ...