Inside the FDA: Why The Pfizer, Inc. (PFE) Boxed Warning On Chantix Is Unlikely To Be Removed

On September 14, the Food and Drug Administration released two briefing documents for the joint meeting of two committees. These are the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

The first briefing was from Pfizer, Inc. (NYSE:PFE) itself, on the merits of its case to remove the boxed warning from Chantix, its smoking cessation aid approved back in 2006 but implicated in neuropsychiatric side effects and suicides in the two years following its approval. A boxed warning was added to the drug in 2009 as a result. The second briefing was from the point of view of the joint review panels, who did not like the way data was collected in the post marketing study to remove the boxed warning.

pio3 / Shutterstock.com

Key parts of the warning label text are as follows:

SERIOUS NEUROPSYCHIATRIC EVENTS INCLUDING, BUT NOT LIMITED TO, DEPRESSION, SUICIDAL IDEATION, SUICIDE ATTEMPT, AND COMPLETED SUICIDE HAVE BEEN REPORTED IN PATIENTS TAKING CHANTIX. SOME REPORTED CASES MAY HAVE BEEN COMPLICATED BY THE SYMPTOMS OF NICOTINE WITHDRAWAL IN PATIENTS WHO STOPPED SMOKING. DEPRESSED MOOD MAY BE A SYMPTOM OF NICOTINE WITHDRAWAL. DEPRESSION, RARELY INCLUDING SUICIDAL IDEATION, HAS BEEN REPORTED IN SMOKERS UNDERGOING A SMOKING CESSATION ATTEMPT WITHOUT MEDICATION. HOWEVER, SOME OF THESE SYMPTOMS HAVE OCCURRED IN PATIENTS TAKING CHANTIX WHO CONTINUED TO SMOKE. ALL PATIENTS BEING TREATED WITH CHANTIX SHOULD BE OBSERVED FOR NEUROPSYCHIATRIC SYMPTOMS INCLUDING CHANGES IN BEHAVIOR, HOSTILITY, AGITATION, DEPRESSED MOOD, AND SUICIDE-RELATED EVENTS, INCLUDING IDEATION, BEHAVIOR, AND ATTEMPTED SUICIDE. THESE SYMPTOMS, AS WELL AS WORSENING OF PRE-EXISTING PSYCHIATRIC ILLNESS AND COMPLETED SUICIDE, HAVE BEEN REPORTED IN SOME PATIENTS ATTEMPTING TO QUIT SMOKING WHILE TAKING CHANTIX IN THE POSTMARKETING EXPERIENCE. WHEN SYMPTOMS WERE REPORTED, MOST WERE DURING CHANTIX TREATMENT, BUT SOME WERE FOLLOWING DISCONTINUATION OF CHANTIX THERAPY.

Pfizer, Inc. (NYSE:PFE)’s document is 114 pages long. The FDA panel document is a much longer 564 pages. Market Exclusive staff combed through these documents and our conclusion is as follows. Spending that much ink reviewing data is a bad sign for Pfizer, and for various reasons primarily centering on the nature of the FDA itself as a regulatory body, the nature of Chantix as being helpful towards but not absolutely necessary for quitting smoking, and the fact that the FDA looks out for itself first (meaning its reputation as generally competent) and only secondarily for the lives of patients affected by its decisions, we feel that the chances of Pfizer, Inc. (NYSE:PFE) scoring a removal of the unwanted label are very low. At best, the wording may be slightly changed, but the chances of even that are comparatively low.