FDA Panel Recommends Chantix Psychiatric Warnings Remain in Black Box

A panel of independent advisors to the FDA voted Thursday to recommended that the current “black box” warning about the risk of Chantix psychiatric side effects should remain in place, rejecting claims by Pfizer that recent evidence justifies removing the prominent information about the risk of suicide, aggression and other unusual behaviors. 

A majority of two FDA advisory committees voted that the agency should require Pfizer to maintain the warning on the smoking cessation drug, which is the most stringent the federal regulatory agency can require, placed in a bold black box at the top of the medication warnings.

Chantix (varenicline) is a prescription medication introduced by Pfizer in 2006, designed to help people quit smoking. However, in 2009, the FDA required Pfizer to add a “black box” warning for Chantix, alerting doctors and patients to a potential link between use of the drug and the emergence of unusual behavior, including suicidal or homicidal thoughts.

In recent weeks, Pfizer has tried to get that warning removed, arguing that new studies raise questions about whether there are any psychological side effects from Chantix.

However, FDA reviewers looked at Pfizer’s data and found it lacking. In a packet of materials prepared for the joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, reviewers wrote that the data Pfizer put forward was “insufficient in quality” and said the Chantix boxed warning should stay.

The FDA advisory panels agreed, with 11 members voting for the black box to remain, six members calling for the warning to be made even stronger, and only one member voting to have the warning removed.

Panel members pointed out that Pfizer should not take into account just the risks to Chantix users, but should also consider the risks to the people around them. Some studies have recorded reports of Chantix users suffering homicidal urges, feeling a compulsion to hurt or even kill those they love.

The FDA advisors indicated it may revise its position after Pfizer finishes a post-marketing study on Chantix that involves 8,000 subjects. The study will compare Chantix side effects to those of two other smoking cessation treatments, in addition to placebo. The findings are expected to be available in late 2015.

The FDA is expected to make a final determination soon. While the advisory committees’ recommendations are not binding on the agnecy, they are often weighed heavily in any final regulatory decisions.

 Calls for Stronger Warnings

Although Pfizer claims that more recent evidence suggests that there is no risk of psychological problems with Chantix, opponents of the label change have indicated that there are numerous studies suggesting the drug is even more dangerous than the label currently indicates.

Last week, five nonprofit organizations sent a citizens petition to the FDA, calling for the current “black box” warnings to be strengthened. Consumer Reports, the National Center for Health Research, the National Physicians Alliance, the Institute for Safe Medication Practices (ISMP), and Public Citizen indicate that the FDA should require Pfizer to clearly describe four specific psychiatric affects associated with Chantix, including suicidal behaviors, aggression and violence, psychosis, and depression.

In addition to strengthening the Chantix black box warning, the groups also want the FDA to add restrictions to the Indications section warning that the drug should not be used by those in hazardous professions, such as pilots, air traffic controllers, military missile crews, and emergency response personnel.

Chantix Health Concerns

While Chantix was originally viewed as a potential blockbuster medication to help people quit smoking, sales have been slowed by concerns about the risk of severe psychological side effects and unusually violent or aggressive behavior among users.

The public first began to become aware of the potential Chantix side effects after the 2007 shooting death of Jeffrey Carter Albrecht, former keyboardist for the folk band Edie Brickell and the New Bohemians, who allegedly was suffering a violent psychotic episode sparked by Chantix when he was shot to death by a neighbor. Albrecht thought the neighbor’s house was his girlfriend’s, and was reportedly trying to kick the door down when he was shot.

Reports of Chantix rage ballooned after that, and some studies appeared to verify that the drug caused aggression, and sometimes homicidal tendencies, in some users. It also caused suicidal tendencies as well as vivid and horrific nightmares. There were skits on Saturday Night Live and the term Chantix Nightmare became a pop culture reference.

Pfizer was hit with nearly 3,000 Chantix lawsuits after the FDA added the black box warning. All of the claims alleged that inadequate warnings were provided for users of the medication prior to July 2009. Rather than fighting the claims, the drug maker agreed last year to pay about $300 million as part of a global Chantix settlement agreement that resolved the litigation.