- Pfizer's Chantix (vareniciline) is intended to be used, in addition to counseling or therapy, to aid smoking cessation, the Wall Street Journal reports. The product has a black box warning.
- The Institute for Safe Medication Practices, along with Consumer Reports and several other consumer watchdog organizations, have filed a petition for stronger warnings about severe Chantix-related side effects, including suicidal ideation, psychosis, agitation, and violence.
- In July 2010, the FDA discovered that Pfizer had failed to follow protocol when submitting 26,000 adverse event reports for Chantix, including 150 suicides and other serious events.
In a week, an FDA advisory panel will review the black box warning on Chantix and determine whether it should be removed. In fact, in September, the FDA updated the labeling to soften Chantix's warning about suicidal thoughts—a move that has angered many consumer groups petitioning for stronger warnings.
Pfizer is adamant that the change was based on evidence from a meta-analysis of nearly 2,000 patients, which did not show an increase in suicidal ideation. In response to Pfizer's statement, the petitioning groups are pointing to "methodological flaws" that they say limit the value of the studies Pfizer is citing as a basis for decision-making.
On the other side, Pfizer has said that the data used to support stronger warnings is based on flawed post-marketing surveillance and therefore not valid. Minutes from the upcoming meeting will be available shortly; at this point, it all comes down to the data and how that data is interpreted.