- There's been an ongoing battle, with consumer watchdog groups on one side and Pfizer on the other, regarding the black box warning for the smoking cessation med Chantix (varenicline). The label warns that the drug is associated with a higher than normal risk of suicidal tendencies.
- The FDA has required Pfizer to conduct a large study to evaluate Chantix's psychiatric side-effect profile and determine whether the labeling should be changed based on data from well-designed trials. The FDA has questioned the validity of data from Pfizer's latest studies.
- Pfizer has already paid $300 million to settle more than 2,500 suits involving Chantix.
Last week, BioPharma Dive reported on the concerted effort of watchdog groups to make sure that the black box warning remain a part of Chantix's labeling. But Pfizer is adamant that its latest data supports removal of such a severe warning.
According to Pfizer's newest data, Chantix is comparable to placebo in terms of its impact on suicidal ideation, hostility, and violence. Not so, say consumer groups and many medical experts. on Thursday, an FDA panel will convene to consider the issue more comprehensively. With many detractors accusing Pfizer of employing smoke and mirrors with the Chantix data, the warning will most likely remain intact.