FDA
20th October 2014

FDA Recommends Keeping Serious Chantix Box Warnings

The Chantix packaging has contained one of the strongest warning labels, also known as “black-box warnings”.

FDA Recommends Keeping Serious Chantix Box Warnings

 

Last week, a joint meeting of the FDA’s Psychopharmacologic Drugs and the Drug Safety and Risk Management Advisory Committees confirmed that Pfizer should continue to put the black boxed warning label on its controversial stop-smoking drug Chantix (varenicline tartrate tablets). The materials from this meeting can be found HERE.

The Chantix packaging has contained one of the strongest warning labels, also known as “black-box warnings”, since 2009 following reports of suicidal tendencies and violent or bizarre behavior among some patients. Pfizer Inc., the makers of Chantix had asked the FDA to drop the boxed warning, pointing to recent studies suggesting there is no increased risk of psychiatric problems among people taking Chantix compared to other stop-smoking aids.

The panel, composed of 18 members voted 11-1 that the drug should maintain the serious black-box warnings while the remaining members suggested the language could be altered.

Steven Romano, senior vice president at Pfizer stated that, “We feel the boxed warning is no longer supported by the data we now have.” 

The FDA normally follows the recommendations of its advisory committee, but is not obligated to do so.Pfizer’s request to remove the label will be reassessed in 2015 following the release of the findings of a study conducted by the drug maker (expected in the third quarter). This post-marketing study includes 8,000 smokers either taking Chantix, placebo, nicotine replacement therapies and Wellbutrin in patients with and without prior history of psychiatric conditions. 

Chantix is prescribed twice a day to patients. It was approved by the FDA in 2006, but the warning label was introduced only in 2008. The company also faced lawsuits on claims that the drug caused several people to commit suicide. Some consumer groups such as the Public Citizen, National Center for Health Research and the Institute for Safe Medication Practices have filed petitions with the FDA to strengthen the warning even more.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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