FDA Panel Recommends Keeping Chantix Warning Label

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Federal health advisers say a black box warning about suicide risks with the anti-smoking drug Chantix should remain on the product’s labeling until it can be re-evaluated based on new study information. The twice-a-day tablet has carried the FDA’s strongest warning since 2009, following reports of suicidal tendencies and violent behavior among some users.

What’s the Problem?

On the basis of new information on the risk of severe neuropsychiatric events associated with Chantix, 11 panel members of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee voted to keep the current black box warning, and to reassess the matter after an ongoing clinical trial is complete.

Pfizer, the company that makes Chantix, has petitioned the FDA to remove a boxed warning about suicidality, behavior changes and other psychiatric side effects from the label, citing research suggesting no or minimal psychiatric risk attributable to the medicine. However, since it was approved in 2006, Chantix has repeatedly been linked to severe psychiatric complications, including suicidal ideation and aggressive/irrational behavior. As a result of these problems, FDA placed a black box warning on Chantix in 2009.

Pfizer’s Christopher Wohlberg, MD, PhD, said that on the basis of “convergence” of new data, “it’s time to unring the alarm bell” on Chantix. “We think the available evidence is inconsistent with a boxed warning.”

Most of the FDA panel members disagreed, citing “concerns about the validity of the findings from Pfizer’s meta-analyses and published observational studies.” The panel noted that studies conducted by Pfizer “had a number of study design limitations” which could underestimate the incidence of psychiatric events associated with Chantix.

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