Pfizer Wants Blackbox Chantix Suicide Warning Removed From Label

Following a recent decision by the FDA to revise the drug label for the anti-smoking drug Chantix, adding data on recent studies that suggest the medication may not increase the risk of suicide, Pfizer is urging the federal drug regulators to remove a “black box” warning added to their product in 2009 about the risk of psychiatric side effects. 

Chantix (varenicline) is a prescription medication introduced in 2006, designed to help people quit smoking by reducing the positive feelings that come from cigarettes.

Shortly after it was introduced, concerns emerged about the psychiatric side effects of Chantix, following reports of unusually aggressive behavior, suicidal thoughts and behavior.

In July 2009, the FDA required a “black box” warning about the risk of suicide and other psychiatric problems that may be caused by the medication, which is the strongest label warning that can be placed on a medication. The information remains prominently placed in a box on the label to alert healthcare providers and consumers.

After the release of several studies in recent years that contradict prior findings involving the link between Chantix and suicide, the FDA announced earlier this week that it is updating the Chantix label to add information about these studies.

Pfizer officials now indicate that the inclusion of the new data means that the FDA should remove the black box label warning from their medication, which was previously viewed as a blockbuster product before concerns emerged about the risk of suicide. The drug has also been linked to unexplainable violent tendencies, vivid and horrific nightmares and other psychological side effects.

The FDA has scheduled a joint meeting of two advisory committees of outside experts to review the must up-to-date data on Chantix side effects. The joint meeting of the psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is scheduled for October 16.

The FDA has asked the advisory committees to review the new safety data on Chantix and to make recommendations on whether the label needs to be changed further and how. The advisory committees’ recommendations are not binding, however, their recommendations tend to factor significantly in the FDA’s regulatory decisions.