October 17, 2014 — Eleven members of an FDA advisory panel have rejected Pfizer’s bid to remove a “Black Box” warning about suicide and psychiatric events from the label on Chantix, an anti-smoking medication.
The Wall Street Journal reports the Pfizer presented evidence from a meta-analysis of five placebo-controlled studies. None of the studies showed any difference between Chantix and a placebo for psychiatric side effects.
However, the FDA had “concerns about the validity” of the studies. They also cited “limited precedent” for removing boxed warnings, but suggested Pfizer may be able to update the warning to include information from recent studies.
According to the agency:
“[FDA is] not inclined to remove the boxed warning at this time because of the concern that such action could be interpreted as confirming ‘no association’ between [Chantix] use and neuropsychiatric risk, which is not supported by currently available observational data.”
Chantix helps people quit smoking cigarettes by blocking “feel-good” chemicals that are released when nicotine enters the brain. Chantix was approved in 2006 and it was projected to be a blockbuster drug. Within 18 months, at least 260 psychiatric adverse events were reported to the FDA, including suicidal behavior.
When the FDA added the boxed warning in 2009, they ordered Pfizer to conduct a large study to compare Chantix with bupopion for psychiatric adverse events. The results of that study are expected next year. The FDA says those results must be considered before any changes are made to the boxed warning.
Between 2009 and 2012, Pfizer was hit with about 2,700 lawsuits in federal court involving Chantix. By last year, most of the cases were dismissed or settled for nearly $300 million.