After settling thousands of product liability lawsuits over allegedly inadequate Chantix warnings, Pfizer continues to face criticism from consumer watchdog groups and health experts that are calling on the FDA to require even stronger warnings about the risk of severe psychological side effects.
A citizens petition (PDF) was sent to the FDA on Wednesday by five nonprofit organizations, calling for a prior Boxed Warning added to Chantix in July 2009 to be strengthened even more, adding information about more recent scientific data showing that the medication can lead to thoughts of suicide and violent impulses.
The petition comes as Pfizer has been pushing to weaken the same warnings for Chantix, and as an FDA advisory panel prepares to meet on October 16 to review the safety of the drug.
Participants in the latest petition include Consumer Reports, the National Center for Health Research, the National Physicians Alliance, the Institute for Safe Medication Practices, and Public Citizen. The petition calls for the FDA to require the Boxed Warning 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, like pilots, air traffic controllers, military missile crews, and emergency response personnel.
Chantix Health Concerns
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.
The public first focused on 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.
After the release of several studies in recent years that contradict prior findings involving the link between Chantix and suicide, the FDA announced that it is updating the Chantix label to add information about these studies and is bringing together a panel of advisors next week to look at Chantix safety data.
Pfizer, the manufacturer, claims that the evidence indicates that there is no risk of psychological problems. However, numerous studies have also said that there are such problems. The drug’s manufacturer wants the FDA to focus on those studies that suggest the drug is safe, while the nonprofit consumer watchdog groups want the agency to focus on those suggesting the drug is even more dangerous than the label currently indicates.
Just days ago, the ISMP issued a report which found that no other drug came close to the number of psychological adverse events linked to Chantix in reports to the FDA.
The debate comes as long-running Chantix litigation comes to an end. Since almost immediately after the FDA issued its 2009 Chantix warning, Pfizer was hit with a stream of lawsuits from the drug’s users and even family members who said they lost loved ones due to the drug’s side effects.
Eventually, Pfizer faced nearly 3,000 Chantix lawsuits, which were centralized and consolidated before U.S. District Judge Inge Johnson in October 2009 in federal district court in the northern district of Alabama as part of an MDL, or multidistrict litigation.
Pfizer opted not to try to fight the cases in trial, reaching a Chantix settlement agreement resolving 2,900 cases for about $300 million.
On October 6, Judge Johnson issued an order (PDF) calling for the termination of the Chantix MDL, saying that the coordinated proceedings had done their job.
“In May 2013, Pfizer Inc. announced that it had settled, or entered into definitive agreements or agreements-in-principle to settle, virtually all of the known Chantix claims in the U.S.,” Judge Johnson wrote. “After approximately five years of litigation, the court now has dismissed all the plaintiffs from these proceedings.”
Judge Johnson said there are still a few plaintiffs whose cases are not yet resolved and noted that the court would take future cases that may arise.