Pfizer wants the FDA to remove the “black box” warning from its smoking cessation drug Chantix, but the FDA is pushing back. Last year, the FDA kept the label in place, pending the results of a major study Pfizer was then in the process of conducting, according to Reuters.
The study of more than 8,000 users is now complete, and it supposedly shows that Chantix did not cause an increase in serious neuropsychiatric side-effects.
However, FDA staff disagree. They claimed that there were inconsistencies in data collection, and that the severity of some side effects was mischaracterized. The FDA opinions were part of a preliminary review before a meeting of an advisory panel Wednesday to review the findings of Pfizer’s study.
The black box contains a message that warns Chantix users about suicidal thoughts, hostility, and agitation.
Despite clinical trial results showing it to be safe and well-tolerated by most patients, serious side effects — including suicide and murderous rages — have been reported almost since the day it was first sold. So many users have reported side effects, in fact, that the FDA forced Pfizer to put a “black box warning” on the package, the most severe warning label possible. The black box contains a message that warns Chantix users about suicidal thoughts, hostility, and agitation.
Chantix brought in $671 million for Pfizer last year. In four years, they will lose patent exclusivity, and will be forced to compete with generic versions. Removing the black box warning could help the company maximize profits from the problematic drug before that happens.
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