Sept 12 U.S. Food and Drug Administration
scientists have expressed concerns about a post-marketing study
of Pfizer Inc's drug Chantix, which is aimed at helping
smokers quit, according to documents posted on the regulator's
website on Monday.
The concerns are related to the trial design and data
interpretation of the study, called Eagles, in more than 8,000
The trial compared the effects of Chantix or GlaxoSmithKline
Plc's Zyban with a placebo or a nicotine patch in
patients with and without a history of psychiatric disorders.
Pfizer has been trying to get rid of a serious warning about
neuropsychiatric side effects on the Chantix label.
The documents are part of a preliminary review ahead of a
meeting of outside advisers on Wednesday to discuss the findings
of the trial.
The panel will decide whether the black box warning, the
most severe available, should be removed from the Chantix label.
(Reporting by Natalie Grover in Bengaluru and Toni Clarke in
Washington; Editing by Kirti Pandey)