Last week there was high drama at the Food and Drug Administration. The maker of the stop-smoking drug Chantix (varenicline) wanted the FDA to remove the black box warning for this medication alerting prescribers and patients to serious psychiatric side effects. We had ringside seats to the spectacle and even presented The People’s Pharmacy perspective and case reports from visitors to this website.
The Battle was joined
Pfizer, the maker of Chantix, requested this FDA advisory committee meeting to plead its case that the black box warning be eliminated. Consumer groups, of which we were a part, suggested that the black box warning should stay, and, if anything, be strengthened.
Although unstated, this was a battle between two warring camps: those that only believe in adverse drug events collected from clinical trial data versus those that analyze and accept adverse event reports submitted by health professionals and patients. The latter group won. The FDA advisory committee voted overwhelmingly in favor of keeping the black box warning. The final tally was 18 to 1. Six members of the committee agreed with us that the warning should actually be strengthened!
Boxed Warning for Chantix
“Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX…
“All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. When symptoms were reported, most were during CHANTIX treatment, but some were following discontinuation of CHANTIX therapy…”
To read the entire boxed warning, here is a link to the official prescribing information for Chantix.
Read why black box warnings are important in this recent People’s Pharmacy editorial column.
Pfizer’s Position
Sales of Chantix have declined ever since the boxed warning appeared in the official prescribing information, so it is not surprising that the company would want to delete this language. To convince the FDA, Pfizer cited studies showing that its drug did not increase the risk for depression, suicide or other psychiatric problems compared to placebo or other stop-smoking drugs. The statistics were complicated.
Consumer Perspective
Consumer groups and FDA staffers pointed out there were serious limitations to the Pfizer data. An FDA staffer, Celia Winchell, MD, observed that many of the adverse reports submitted to the FDA contained language that was almost assuredly not used in the clinical trial coding. She described symptoms such as “feeling like a zombie,” or “couldn’t get out of bed” as examples of patient experiences that might easily have been coded incorrectly.
During our testimony we confirmed that we started receiving reports of serious depression in people taking Chantix in the summer and fall of 2007, long before the FDA strengthened warnings about psychiatric side effects. We also heard about acts of violence linked to Chantix, especially in people who had been drinking alcohol. We have received over 1,000 messages in the form of comments to this website, email communications and letters. The vast majority note serious psychological complications from Chantix.
The Patient Experience
“I started taking Chantix in September. I went through the second dose pack, then had to quit. I ended up in the mental unit at the hospital because I was having severe panic attacks and suicidal thoughts.
“It started about a week after starting the drug, but I continued taking the pills thinking the symptoms would go away. They didn’t, so I had to stop.
“I have been smoke free since then. This medication will definitely help you stop smoking. But your life may never be the same. I now cannot have a relationship with my children or my grandchildren because of the depression and the anger. I miss and love all of them but I don’t want to hurt them.
“I have had a big change in my personality. I’m not the same person anymore. I really have no feelings about anything or anybody. It’s really sad to live like this. I miss my family. The depression and the suicidal thoughts are there every day. I have been many places for help, but nothing has worked.
“I have lost my home and the people I know I still love. This is no way to live your life. I am having chest pain and arm pain and am still having severe panic attacks. My depression is getting worse. I don’t want to go out or see anyone. I can’t think straight. My life as I once knew it is over and I don’t think I will ever get it back.” Suzann
Bottom Line:
Most health professionals have a hard time imagining that a drug that was taken for only a few weeks could cause lasting side effects. And yet we have heard from others that stopping Chantix does not always lead to prompt reversal of depression, suicidal thoughts or aggression. Some people have complained that the psychological changes have lasted for months or longer.
Everyone agrees that smoking is one of our greatest health hazards. No one at the FDA hearing was calling for the removal of Chantix from the market. But we all want patients to be well informed of the potential complications.
A black box warning is the strongest warning there is for any medication. Hopefully, it will encourage prescribers to notify people of possible side effects before they start taking Chantix. If symptoms emerge, family members will be prepared to take immediate action to prevent depression or aggression from getting out of hand.
We welcome your thoughts on this controversial matter below.
