NEW YORK CITY (dpa-AFX) - An advisory panel of the U.S. Food and Drug Administration voted to keep boxed warnings of neuropsychiatric risks on the label for Pfizer inc.'s (PFE) smoking-cessation drug Chantix.
In April, Pfizer submitted a labeling supplement for varenicline (Chantix) proposing changes to its labeling relating to the risk of serious neuropsychiatric adverse events.
In the cover letter of this supplement, Pfizer asserted that, '.since 2009, more reliable data on the NPS [neuropsychiatric] safety of Chantix have become available, including meta-analyses of placebo-controlled clinical trials and data from observational studies comparing varenicline to other smoking cessation pharmacotherapies. As presented in this submission, these data do not support an association between treatment with Chantix and serious NPS [neuropsychiatric] events.'
Based on FDA's review of the meta-analyses and observational studies submitted by Pfizer, FDA determined that some information about these data could be included in the varenicline labeling.
This was for prescribers to have a full picture of what analyses and studies have been conducted to enhance the understanding of varenicline-associated serious neuropsychiatric adverse events.
Regarding whether to remove a boxed warning, FDA said it believes that the randomized controlled trial to evaluate the risk of serious neuropsychiatric adverse events with varenicline, whose final study report is expected in a year, should be reviewed and considered as part of such a regulatory action.
In a Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, the panel voted11 in favor of retaining the warnings, while six members suggested modifications and one member favored removal.
Several panel members also believed that sleep disturbances should be added to the warnings.
PFE closed down 1.7 percent at $27.70.
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