- Pfizer's Chantix (vareniciline) is indicated for smoking cessation, but carries an FDA warning associated with increased risk of depression and heart attack.
- A new six-month study tracking 150,000 patients in England has shown that patients who take Chantix did not have an increased risk of depression or heart attack.
- Chantix had $647 million in sales in 2014.
According to experts, every year of smoking reduces lifespan by three months. For this reason, some smoking-cessation advocates would like to remove Chantix's black box warning for depression, which was added in 2009. In addition, they would like the black box warning for increased risk of heart attack, which was added in 2011, to be removed.
It should be noted that in the large-scale British study, Chantix was compared with Zyban (buproprion) from GlaxoSmithKline. All told, the risk of depression or desire for self harm was comparably low in both arms—at least according to this review.
The full study is available in the latest issue of The Lancet Respiratory Medicine. But the bigger question is: Will it prompt regulatory agencies to change their tune on the drug? In the U.S., the FDA added new alcohol and seizure warnings to the drug back in March and has consistently denied Pfizer's requests that the black box warnings be nixed.