Chantix: Why the Black Box Warning is Not Enough and Drug Should Be Removed from the Market

Editor’s Note:  What is the metric to be used to judge anti-smoking therapies?  “Modified Risk” determinations are to apply to the entry of new tobacco products; should the metric being developed by the Institute of  Medicine apply to anti-smoking therapies?

Siegel: Rest of the Story

Yesterday, I called for the removal of Chantix from the market, arguing that the black box warning was not adequate to protect the public from the severe adverse side effects that have been observed with the drug. Today, I explain why it is that the black box warning is not sufficient to protect consumers.

The black box warning for Chantix notes the following:

“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. … Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior.”

The black box warning, then, advises physicians to observe patients being put on Chantix for “suicide-related events,” including “suicide.”

This simple question comes to mind: What use is it to observe patients for suicide? In what way does that protect the consumer? If a side effect of the medication is committing suicide within days of initiating therapy, how is monitoring the patient for suicide going to help?

The FDA itself has reported a typical case of Chantix-associated suicidal ideation as follows: “A 30 year-old female reported that she was taking varenicline 0.5 mg/day to help her quit smoking. She indicated that she had taken the pill for 5 days as directed. In her report, she stated, ‘I became very depressed for no apparent reason and started having suicidal thoughts. I worried that I was going to hurt myself or someone else. I was also in a state of panic and unable to eat. I thought that I might go crazy and felt completely out of sorts. I quit taking the pill. About 36 hours later, I felt like myself again.'”

Fortunately, this woman stopped taking the medication. However, the story could easily have been different. Instead of stopping the medication, she could have instead attempted or committed suicide in response to her suicidal ideation. Monitoring patients like this for suicide attempts makes no sense. The purpose of monitoring is to prevent these adverse consequences -especially death – from occurring.

There are three situations in which a black box warning can be effective in protecting consumers. I will describe each of these situations and show why Chantix does not meet any of these criteria:

1. Early Detection of Side Effects Can Prevent Serious Adverse Consequences

One situation in which a black box warning may be appropriate is when monitoring of early side effects can prevent serious consequences. For example, if a side effect of a medication is liver damage, then monitoring a patient’s liver enzymes for evidence of early liver injury can prevent serious disease by alerting the physician to this side effect so that the medication can be discontinued before it causes actual liver damage.

Chantix does not meet this criterion because its most worrisome side effect – sudden suicide – often occurs without warning, often in a matter of days following initiation of therapy. Relying on patients who become depressed to call their physician to report the symptoms is ineffective because one of the symptoms of depression is the inability to do just that. That the most worrisome side effect is not just depression but frank suicidality makes the black box warning ineffective in this regard.

2. Restricted Use of the Drug May Prevent Side Effects

A second situation in which a black box warning may be appropriate is when the severe side effects of the drug tend to occur only in certain patients. In this situation, warning physicians not to prescribe the drug to those patients can prevent the serious side effects. For example, if a drug causes blood clots only in people who are obese, then warning physicians not to prescribe the drug to patients who are obese will be effective in preventing this side effect.

This is not the situation with Chantix because its potentially lethal side effects have been observed to occur among all patients, not only those with existing psychiatric disease. In fact, FDA’s review of Chantix side effects revealed that of cases of Chantix-related suicidal behavior in which psychiatric history was known, 44% of victims had no prior history of psychiatric disease.

3. The Benefits of the Drug Far Outweigh the Costs and Despite the Severe Side Effects, Physicians Should Use the Drug if Benefits Outweigh Risks for a Specific Patient

The third situation in which a black box warning may be appropriate is if the benefits of the drug far outweigh the costs on a societal level and the warning will ensure that physicians weigh the costs and benefits of the drug for the specific patient. For example, a drug that is used to treat cancer might have a severe adverse side effect but its benefits might still outweigh this cost if there are no other treatments available and so this is the only choice that patients have. This criterion will generally not be met if there are lots of other drugs on the market that are equally effective.

In my view, this criterion is not met for Chantix because this drug is not uniquely effective. There are many other treatments on the market (including a variety of nicotine replacement medications) that are equally effective. Moreover, the overall success rate with Chantix is still exceedingly low, and in the overwhelming majority of cases, the use of Chantix will not succeed in getting the patient to quit.

Under these circumstances, I simply do not see how the benefits of keeping Chantix on the market outweigh the many deaths that it has caused. It is not like this is some sort of wonder drug that is very effective in helping people quit smoking, nor is it like this drug is so much more effective than other smoking cessation drugs on the market.

Since none of these three criteria is met, I do not believe that the black box warning is appropriate and I reiterate my call for the removal of Chantix from the market.


4 comments. Leave a Reply

  1. TERRI

    You’re right, ya know. On all counts. I took two scripts back/back in ’07. Endured two, long hospital and psyche unit stays in ’08. This is one, scary, drug.

    While it DID touch on the smoking receptors…it didn’t stop there. And, THAT’S where the problem comes in! Once in the bloodstream, it grew feet! Depositing seeds all throughout my brain…distorting… TWISTING…thoughts, dreams, reflexes. Got to the point I could no longer decipher my “state.” Dreams were so real and so vivid,…I’d have to wait a few minutes before getting out of bed.

    I trusted everyone involved in the process of getting this script, my doctor, Pfizer, pharmacist and MOST of all FDA. Never again. Learned the hard way…no one has your back. No one.

  2. Everett Kelly Baker

    I was taking Chantix for three weeks and suffered a stroke. Then a year later I had a heart attack. This medication should not be on the market.

  3. Andrea

    my 24 year old, highly intelligent and capable daughter suddenly disowned me, my husband AND the entire family after coming off Chantix. She called the police when I tried to visit and find out what’s wrong. After 24 years of a VERY close relationship, I have not seen nor spoken to her in over 10 months. I am devastated. I blame Chantix and can do nothing about it.

  4. Kev

    A few months ago, my doctor prescribed Chantix to help me quit smoking. We had a short discussion about about the drug and its potential side effects (irritability, anxiety), so I thought I was prepared.

    The first week on Chantix was OK, just a few very vivid dreams (nothing nightmarish). About half-way through the second week, though, I started getting irritable. And not just irritable, but aggressive. By the end of the week I was firing off e-mails to family, friends and colleagues about trivial matters that had never made me feel angry before. I was calling my partner a “fucking idiot” for getting answers wrong on Jeopardy.

    In Week 3, things got worse. I began accusing my partner, family and friends of conspiring against me. Even during the most basic social interactions with strangers I found myself imagining that they were secretly thinking horrible things about me. And I was also getting very forgetful… forgetting where I’d put things in the house, sending second (sometimes even third) e-mails to people that I’d already replied to, all saying the same thing; forgetting what day it was, and even what month it was.

    The most frightening experience was when I was driving on the highway and had a sudden, overpowering feeling that I was either going to be involved in an accident, or cause one. At one point, I even began fantasizing about driving off the road.

    My doctor recommended weaning myself off Chantix over a 2-3 week period. I’ve been off the drug for nearly a week now. I’m still feeling fragile (also exhausted), but at least I’m not having delusional thoughts. That’s a start. I do worry, though, about some of the internet reports I’ve read of people who continued to experience paranoia and anxiety long after they quit using the drug.

    Even though the patch didn’t work well for me the last time I tried to quit smoking, I’ll try it again. I need to quit smoking, but Chantix was not the solution for me.

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