Chantix Black Box Warning on Psychiatric Side Effects Should Remain: FDA Reviewers

As debate continues over the need for psychiatric warnings for Chantix, FDA staff reviewers indicate that the smoking cessation drug should continue to carry a black box warning to alert users about the risk of suicidal thoughts, violent behavior and other unusual actions while taking the medications. 

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

Shortly after the medication was introduced, concerns emerged about a link between Chantix and suicide, leading the FDA to require a “black box” warning in July 2009, which is the strongest warning that can be placed on a prescription drug.

In recent weeks, Pfizer has been pushing the FDA to remove the Chantix black box warning, indicating that the findings of some recent studies have raised questions about whether the warning is necessary. However, several consumer advocates have opposed the move, suggesting that the Chantix warnings should actually be strengthened.

In preparation for an FDA advisory meeting slated to begin tomorrow, staff reviewers for the FDA published their own Chantix label recommendations (PDF), indicating that the warning should remain placed prominently on the drug label in a black box.

The FDA typically only removes an existing Boxed Warning under rare circumstances, which the staff reviewers indicate Chantix does not appear to meet. Furthermore, the reviewers found that Pfizer’s evidence refuting the Chantix suicide risk were “insufficient in quality” to merit removing the warning.

The materials were released before a joint meeting of the Pschopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The two committees will review evidence and testimony starting tomorrow, and then give advice to the FDA on what, if any, actions need to be taken.

While the recommendations issued by FDA advisory committees are not binding, the agency often weighs them heavily in making any final regulatory decisions.

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.

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.

Pfizer was hit with nearly 3,000 Chantix lawsuits, alleging 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.

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.

Earlier this month, Institute for Safe Medication Practices (ISMP) issued a report that indicated Chantix was linked to more thoughts of suicide than any other drug monitored by the group.

Between 2007 and 2013, ISMP indicates that Chantix was associated with at least 2,748 adverse event reports submitted to the FDA involving suicide, self-injury or homicidal ideation. The next closest medication, which was the asthma drug Singulair, only accounted for 835 cases during that same period; less than one-third the number linked to Chantix.