Chantix does it work

What is CHANTIX?

CHANTIX® (varenicline) is a prescription medicine to help adults 18 and over stop smoking. CHANTIX helps reduce the urge to smoke.

How is CHANTIX different from other smoking cessation products?

CHANTIX is a non-nicotine pill. CHANTIX targets nicotine receptors in the brain, attaches to them, and blocks nicotine from reaching them.

What should I tell my doctor before starting CHANTIX?

Tell your doctor about all your medical conditions including if you:

  • Have ever had depression or other mental health problems, as these symptoms may worsen while taking CHANTIX.
  • Experienced nicotine withdrawal symptoms with prior quit attempts, with or without CHANTIX. Quitting smoking, with or without CHANTIX, can result in nicotine withdrawal symptoms (such as depressed mood, agitation) or a worsening of existing mental health problems, such as depression.
  • Have kidney problems or get kidney dialysis. Your doctor may prescribe a lower dose of CHANTIX for you.
  • Have a history of heart or blood vessel problems before starting CHANTIX. If you have new or worse heart or blood vessel symptoms during treatment, tell your doctor. Get emergency medical help right away if you have any symptoms of a heart attack or stroke.
  • Are pregnant or plan to become pregnant. CHANTIX has not been studied in pregnant women. It is not known if CHANTIX will harm your unborn baby. It is best to stop smoking before you get pregnant.
  • Are breastfeeding. Although it was not studied, CHANTIX may pass into breast milk. You and your doctor should discuss alternative ways to feed your baby if you take CHANTIX.

Tell your doctor about all your other medicines including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take:

  • Insulin
  • Asthma medicines
  • Blood thinners

When you stop smoking, there may be a change in how these and other medicines work for you.

You should not use CHANTIX while using other treatments to quit smoking. Tell your doctor if you use other treatments to quit smoking.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

How do I take CHANTIX?

  1. Choose a Quit Date when you will stop smoking.
  2. Start taking CHANTIX one week (7 days) before your Quit Date. This lets CHANTIX build up in your body. You can keep smoking during this time. Make sure that you try and stop smoking on your Quit Date. If you slip up, try again. Some people need a few weeks for CHANTIX to work best.
  3. Take CHANTIX after eating and with a full glass (8 ounces) of water.
  4. It is recommended to take CHANTIX for a full 12 weeks. If you have completely quit smoking by 12 weeks, ask your doctor if another 12 weeks of CHANTIX may help you stay cigarette-free.

CHANTIX comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet.

  • This dosing schedule may not be right for everyone. You may need a lower dose of CHANTIX if you have kidney problems or get dialysis.
  • If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, wait. Just take your next regular dose.

What is the safety information and possible side effects of CHANTIX?

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family, or caregiver notice agitation, hostility, depression, or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Do not take CHANTIX if you have had a serious allergic or skin reaction to CHANTIX. Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

Before starting CHANTIX, tell your doctor if you have a history of heart or blood vessel problems. If you have new or worse heart or blood vessel symptoms during treatment, tell your doctor. Get emergency medical help right away if you have any symptoms of a heart attack or stroke.

Use caution driving or operating machinery until you know how CHANTIX may affect you.

In clinical trials, the most common side effects of CHANTIX include:

  • Nausea (30%)
  • Sleep problems (trouble sleeping, changes in dreaming)
  • Constipation
  • Gas
  • Vomiting

These are not all the side effects of CHANTIX. Ask your doctor or pharmacist for more information.

A side effect is a negative or positive effect related to a medicine based upon clinical studies.

Tell your doctor about these side effects that bother you or that do not go away.

How long should I take CHANTIX?

It is recommended CHANTIX be taken for a full 12 weeks or as prescribed by your doctor. If you have completely quit smoking by 12 weeks, ask your doctor if another 12 weeks of CHANTIX may help you stay cigarette free.

Should I take CHANTIX on an empty stomach?

Doctors recommend you take CHANTIX with food and a full glass (8 ounces) of water.

What do I do if I miss a dose of CHANTIX?

If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, wait. Just take your next regular dose.

What if I slip up while taking CHANTIX?

It’s okay. Remember, you may choose to smoke for the first week you are on CHANTIX. Try to stop smoking completely on your Quit Date (Day 8). But if you slip up, don’t give up! Some people need a few weeks for CHANTIX to work best. In studies, 44% of CHANTIX users were quit during weeks 9 to 12 of treatment (compared to 18% on sugar pill). Some people who smoked after their Quit Date were able to quit successfully.

Will my urge to smoke go away when I take CHANTIX?

You might still feel some urge to smoke. But it might be less than you’d have without CHANTIX. Remember, it’s possible that you might slip up and smoke while taking CHANTIX. If you do, you can stay on CHANTIX and keep trying to quit.

Who should not take CHANTIX?

CHANTIX has not been studied in children under 18 years of age. CHANTIX is not recommended for children under 18 years of age.

Do not take CHANTIX if you are allergic to anything in it. See a complete list of ingredients below.

You should not use CHANTIX while using other treatments to quit smoking. Tell your doctor if you use other treatments to quit smoking.

What is in CHANTIX?

How should I store CHANTIX?

  • Store CHANTIX at room temperature, 59 to 86°F (15 to 30°C)
  • Safely dispose of CHANTIX that is out of date or no longer needed
  • Keep CHANTIX and all medicines out of the reach of children

What is the GETQUIT® Plan?

GETQUIT is the support plan developed to work with CHANTIX. GETQUIT offers:

  • A 7-day pre-quit plan that provides specific topics and activities to help you prepare for your Quit Date
  • A full year of support with activities and messages to help you learn how to stay quit
  • Learn more about GETQUIT

How can I sign up for GETQUIT?

If you are already taking CHANTIX, or have a prescription, you can sign up for GETQUIT. When you fill your prescription for CHANTIX at the pharmacy, you’ll receive an enrollment card inside your box of CHANTIX. Find the number on the back of the enrollment card. Or, if your prescription comes in a bottle, find the prescription number on your pill bottle. Then go to www.getquit.com or call 1-877-CHANTIX (242-6849) and follow the instructions to enroll and set up your personalized support plan. If you have lost your card or don’t have one, call 1-877-CHANTIX.

What is CHANTIX

CHANTIX is a prescription medicine that, along with support, helps adults 18 and over stop smoking. You may benefit from quit-smoking support programs and/or counseling during your quit attempt. It’s possible that you might slip up and smoke while taking CHANTIX. If you do, you can stay on CHANTIX and keep trying to quit.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Photo: Tim Richardson

Things were looking good. My doctor had gone through the test results and told me I was perfectly healthy—except my breathing was a little shallow. That didn’t surprise me. I’d been smoking for twelve of my 32 years, and my father died of lung cancer in his early fifties. That’s why I was having my first physical in five years: I’d decided it was time to stop for good.

I’d heard about Chantix, a relatively new drug from Pfizer that blocks nicotine from attaching to your brain receptors. That way, you stop receiving any pleasure from cigarettes at all—even as the drug, snuggling up to those receptors the same way nicotine does, reduces withdrawal cravings and unleashes a happy little wash of dopamine to boot. Wonderful things they can do nowadays.

My doctor wished me luck as he wrote out the prescription, telling me it was the single most important decision I’d ever make in my life. I had the medication that night, 35 minutes after dropping into Duane Reade. While waiting, I gleefully chain-smoked Parliament Lights. One of Chantix’s big perks is that you can smoke for the first seven days you’re on it (most people take it for twelve weeks)—more than enough time, I thought, to say good-bye to an old friend.

I swallowed my first pill the next day before work. It was a beautiful fall morning, an almost obnoxiously cinematic day to turn over a new leaf. But by the time I was halfway to the office, I started to feel a slight nausea coming on. Of course, that is a common side effect, as are constipation, gas, vomiting, and changes in dreaming. These five symptoms were emblazoned in a large font on the patient-information sheet.

My stomach settled as I finished my first cup of coffee. I slipped into my boss’s office, proudly announcing that I’d just started taking Chantix. “You’ve probably seen the commercial,” I said. A CGI tortoise races against a sprightly CGI hare, while a paternal voice-over reminds us that quitting smoking “isn’t for sprinters … it’s all about getting there!” Clinical trials demonstrated a whopping 44 percent of patients were still off cigarettes after twelve weeks, the ad says. The tortoise winks knowingly.

“You know, I saw something about Chantix,” my boss said, sounding vaguely concerned. He tracked down the story on a CBS Website. It was a sensational report on Carter Albrecht, a Dallas musician formerly with Edie Brickell & New Bohemians. Albrecht had started taking Chantix with his fiancée, with seemingly dramatic side effects. She claimed he had had bizarre hallucinations that worsened when he drank. One evening, he attacked her, something he’d never done before. He then ran to his neighbor’s house and kicked at the door, screaming incomprehensibly. The neighbor was so panicked he wound up shooting Albrecht through the door, killing him.

I tried not to roll my eyes. It seemed obvious this was nothing more than scaremongering—perhaps Big Tobacco had launched a spin campaign. Millions of Americans were on Chantix. Why focus on the negative?

The next night, I nodded off listening to Radiohead’s In Rainbows, feeling a little guilty that I’d paid zero dollars for it. I had a quick blip of a dream: A dark, inky fluid was jolting violently from the corners of my ceiling, zigzagging its way across the walls and wooden floor in jerky sync to the music.

It was only a dream, though it seemed more immediate and visceral than my usual fare, which I rarely remember after waking up. The following night, things got even stranger. I fell asleep with Bravo blaring on my TV and dreamed that a red-faced Tim Gunn was pushing me against the wall. “But I always thought you were so nice,” I said.

By night four, my dreams began to take on characteristics of a David Cronenberg movie. Every time I’d drift off, I’d dream that an invisible, malevolent entity was emanating from my air conditioner, which seemed to be rattling even more than usual. I’d nap for twenty minutes or so before bolting awake with an involuntary gasp. I had the uneasy sense that I wasn’t alone.

I smoked a cigarette, then tried going back to sleep. But each time I started napping, I’d dream that something increasingly ominous—carbon monoxide? Vampires?—was sucking vital essence out of me. Soon the clock on my desk read 3:20 a.m.

The most unsettling thing about sleeping on Chantix is that I never felt like I was truly asleep. Some part of me remained on guard. It was more like lucid dreaming, what I thought it might feel like to be hypnotized. And it didn’t entirely go away come morning. As I showered, shaved, and scrambled into clothes, I tried to shake a weird, paranoid sense that I’d just been psychically raped by a household appliance.

Photo: Tim Richardson

On January 25, Pfizer was able to share some good news: Japan—where 40.2 percent of all men still smoke—had green-lighted the manufacturing and marketing of its smoking-cessation drug. But a few days later, the Chantix news was less cheering. On February 1, the Food and Drug Administration warned that Chantix, which had fourth-quarter sales of $280 million (up from $68 million a year ago), could cause serious psychiatric problems, including suicidal thinking. Several weeks earlier, Pfizer had independently changed the small-print booklet that accompanies all drugs to say “All patients … should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” (Previously the fine type had listed suicidal ideation as a rare adverse reaction.)

Now, after investigating an escalating number of complaints from doctors, patients, and health-care providers, the FDA was citing 34 suicides and 420 instances of suicidal behavior in the U.S. Couldn’t those cases have had to do with depression brought on by nicotine withdrawal, compensatory dopamine notwithstanding? Perhaps, said the agency, but some occurred among people who were still smoking while taking the pill.

Varenicline, Chantix’s chemical name, was approved by the FDA in 2006. In development for over a decade, it is the first smoking-cessation medicine designed to work specifically on nicotine receptors, and at first glance, it would appear that it performed quite well in testing. “At week 12, we looked at how many of the smokers didn’t touch a cigarette for the last four weeks of treatment,” says Dr. Anjan Chatterjee, a medical director at Pfizer. “Forty-four percent.” But the tortoise in the ad doesn’t say how patients fared later on. “About 23 percent still hadn’t taken a puff from week 9 to week 52,” Chatterjee admits. “So the relapse rate was about 77 percent.” Still, that’s not bad given that only 7 percent of smokers using the nicotine patch or gum are still off cigarettes after six months.

A total of 3,659 people were handpicked for the Chantix tests before it came on the market, an almost equal number of men and women, with an average age of 43. Nearly all were white, and the tests excluded anyone with a history of depression, panic disorder, heart disease, kidney or liver problems, alcohol or drug abuse, and diabetes. These exclusions aren’t mentioned in the original “Who Should Not Take Chantix” part of the patient-information sheet, which merely states that the drug wasn’t tested on people under 18. (Pfizer does tell patients they should let their doctors know if they have kidney problems or take insulin.)

For me, self-destructive fantasies began cropping up as cartoonish flights of fantasy—nagging chatter that became a little more concrete with every passing day.

Around 5 million prescriptions have been filled in the U.S. thus far. So why would so many groups have been excluded from the testing, particularly for a drug with such potential mass appeal? “In order to satisfy the FDA’s criteria, we have to isolate all the different variables that could affect the outcome,” says Chatterjee. “We can’t use very sick people or people who would not tolerate the drug.” An FDA spokesperson acknowledges this: “It’s not unusual to exclude people with major medical or psychiatric illnesses from some clinical trials,” says Susan Cruzan.

“When they tested the drug, the sample they chose simply isn’t representative of the people they’re targeting,” says Dr. Daniel Seidman, the director of Smoking Cessation Services at Columbia University Medical Center. “By excluding drinkers, you’re artificially inflating your results, potentially. I run a clinic, and two out of three I see have a psychiatric or mood problem. None of these people would have been part of the original trials.”

Public Citizen, a consumer-advocacy group, recommends that people not use Chantix—or most new drugs, for that matter—for seven years. “The first seven years are when problems will occur,” says Dr. Sidney Wolfe, editor of Worstpills.org.

“I remember hearing that argument,” Chatterjee said, a few weeks before the FDA’s new warning was issued. “And it’s just so illogical. If no one uses the drug for seven years, there’s no one to report experiences at the end of seven years—so you’re exactly where you were at the beginning.”

While I was on Chantix, I didn’t scan Websites for news about it. As my dream life continued plunging into strange and increasingly grotesque territory, I did think of Carter Albrecht a couple of times, but his story still seemed strictly outlier, a freakish occurrence. As Chatterjee would explain, “What we know of the story has only come from the press. But the level of alcohol in his body was over three times the legal drinking limit in Texas. In the controlled clinical trial, these kinds of changes in behavior were extremely rare, occurring almost as often as the placebo. Based on the tests, we have no evidence of any kind of consistent relationship between Chantix and aggressive behavior.” Nor was the rate of depression any different between those taking Chantix and those on a placebo.

Photo: Tim Richardson

It wasn’t until after I’d stopped taking Chantix (and switched to the patch) that I would read about other cases, ones in which violence was directed inward rather than out. In December, Omer Jama, a TV news editor in the U.K., slashed his wrists and died, a few weeks after going on Champix. (In the U.K., Chantix is known as Champix, but the FDA objected to that name because it was “overly fanciful and overstates the efficacy of the product.”) Shortly thereafter, a 36-year-old welder hanged himself after completing a thirteen-week Champix regimen.

The term suicidal ideation looks pretty dead on the page, and if you were ever to experience such a symptom, it’s unlikely you’d pick up on it right away: “Here comes that damned suicidal ideation again. I had better call my physician.” For me, self-destructive fantasies slowly began cropping up as cartoonish flights of fantasy—nagging, almost imperceptible chatter that became a little more concrete and domineering with every passing day.

A week into my Chantix usage, I started to feel as if the city landscape had imperceptibly shifted around me. Mundane details began to strike me as having deep, hidden significance. The neon arch above McDonald’s: The lights blinked on and off in some sort of pattern, and I needed to crack the code. One of my co-workers was messing with some papers: What is he trying to imply with all that damned crinkling? Sitting in the subway: A man hurries to get inside. His hand, holding a cup of coffee, gets stuck in the closing door. I watch the hand wriggle. The lid bursts open and steaming brown liquid hits the floor. Fingers twitch and splay. Coffee splashes in crisscrossing slats through the subway car. It was a sign—something bad was going to happen.

It felt as if the essential barrier between reality and my imagination had eroded. Was it because I wasn’t getting enough R.E.M. sleep, so my dream life was rebelling, pouring into daylight, insisting to be attended to, one way or another?

Meanwhile, smoking cigarettes had become an exercise in futility. At work, I’d put on my coat, head out, and light up—but there was no pleasure to be found, just a truly nasty taste.

One afternoon, I was typing away at advertising copy, and as I did so, I began to wonder how I had succeeded in fooling myself that my life had any sort of value at all. Writing? Sure, it was what I’d wanted to do since I was 6—but at the end of the day, who cared? Maybe I should just go downstairs and leap in front of a tour bus. Or launch my head through the computer screen. All this seemed logical, but also weirdly funny, even at the time: I could see how crazy these impulses were, I could recognize them as suicidal clichés. But I couldn’t make them go away.

I’d wake up with my clothes on, music blasting, and strange half-eaten sandwiches lying on the floor that I had no recollection of buying.

A few minutes later, they did, and I thought, Who was the depressed seventh-grade goth girl who had just muscled into my brain? I hadn’t thought of suicide in any serious way since I was a teenager, and that had just been adolescent posturing. I had no interest in killing myself—that’s why I wanted to quit smoking in the first place.

Seidman, who has seen only a handful of patients on Chantix, says that “one guy said he was having waking nightmares—actually experiencing nightmares while he was awake.” Last week, Dr. Mary O’Sullivan, the director of the Smoking Cessation Program at St. Luke’s–Roosevelt (who, like Seidman, says she has no ties with Pfizer), saw her first Chantix patient with “suicidal ideation.” This “was quite a shock,” she says. “He had no background in mental illness, no underlying tendency to depression.” However, before then she had “given it to well over 200 patients without a single side effect.” And she still believes that in terms of smoking cessation, “it’s been a miracle drug.”

“I haven’t seen suicide in patients, and I haven’t seen psychotic breaks, either,” says Dr. Elliot Wineburg (also no Pfizer affiliation) of the Mount Sinai School of Medicine. “But as far as people successfully quitting smoking, I also haven’t seen great results.”

My own, spectacularly unscientific survey of people on the drug was equally mixed. “It’s getting easier by the day,” says Nicholas Bullock, a 27-year-old art director. “And the nausea has stopped as well.” Others said Chantix worked but left them feeling temporarily lobotomized. Chris Masters, a 26-year-old investment-firm manager, began experiencing “daytime hallucinations. In the car, I’d feel my cell phone vibrate and roll the window down.” On the way to a wedding in the country, “I decided I would plow into a herd of sheep if the street I was looking for didn’t come up soon.” And then there’s Elizabeth McCullough, a 48-year-old musician. “Chantix made me desperately suicidal, just crazy,” she says. “I joked to my friends that Chantix was the ultimate quit-smoking drug, because when you kill yourself, there’s no chance of relapse.”

Since the FDA’s announcement, those hare-and-tortoise commercials seem to have disappeared from the airwaves. Is the voice-over being retooled? “Yes, we’re currently updating our branded campaign in order to reflect the changes to the label,” says Francisco Debauer, a Pfizer spokesperson. “In the meantime, we’ll be airing our unbranded ad in TV and print”—the My Time to Quit campaign, which never mentions Chantix, but directs people to a Website that eventually leads to them to another, which does.

The drug would appear to be at a crossroads—perhaps the worst, rarest adverse reactions have been reported, perhaps more cases are still to come. Pfizer says no lawsuits have been filed, but there are certainly injury lawyers hungrily putting up Chantix Webpages. Smokers who want to quit are left with a more difficult decision—and the strong advice, if they do take the drug, to be on the lookout for mood changes.

After a few weeks on Chantix, I had managed to stop smoking altogether—but it didn’t feel like a triumphant turn of events. I’d become rather reclusive, avoiding calls from friends, and basically just shuttling back and forth between my office and my apartment. I began to dread six o’clock; it meant I had to walk through the streets again. The subway was now out of the question; it made me too nervous. I stopped going to the gym, too.

I wondered whether Chantix was zapping my brain’s pleasure-delivery system to such a degree that not only did I find no reward in cigarettes, but I also found no reward in socializing, exercising, writing, or any of my usual self-stimulating tricks. I’d pace the floor, sit on the bed, channel surf, pace some more, try to read, but the room had a stale, sinking feeling. Maybe I should go and grab a drink—then at least I might be able to get some rest.

There was no warning against drinking while on Chantix, and even if there had been, I can’t say with any honesty that I’d have adhered to it. (I wasn’t taking any other medication, though.) But while I’ve had my fair share of dark and drunken nights over the years, what I experienced on Chantix was something else altogether. One evening, I steeled myself to go on a date, but after a few drinks with the guy, I abruptly burst into tears mid-sentence. The crying jag lasted about 30 minutes, with the thought I can’t do this anymore looping through my head. This was happening a lot lately, as though someone had spliced other people’s thoughts into the tape whirl of my brain.

Another night, at an East Village bar, an older man in a trench coat caught my attention. I chatted him up for a while, until I realized I was actually trying to go home with the shadow cast by a potted plant. With alcohol in my system, I was somehow able to take this hallucination in stride: “The man who got away … ” But that same evening ended with my taunting a skinhead who was improbably on the corner of Avenue A and 14th Street. “You must be lost,” I snapped. “Are you looking for 1993?” He ended up chasing me into a deli and saying he was going to murder me. (The guy at the register called the cops and the skinhead fled, so I’m fairly confident that he, at least, was real.)

I’ve blacked out a handful of times before, but now it wasn’t unusual to have five or six hours completely wiped out of my memory. I’d wake up with my clothes on, music blasting, and strange half-eaten sandwiches lying on the floor that I had no recollection of buying. One morning, I found an unopened container of dental floss in my coat, as well as a batch of business cards from people whom I couldn’t remember at all. Later that day I received a text message: “I had a great time meeting you … I could have talked to you for another two hours. :)” I have no idea who that person was.

Why didn’t I just stop taking the drug? I did consider it. But there’s something particularly dispiriting about quitting a medicine that’s supposed to be helping you quit smoking. I kept thinking that my body was still getting used to being on Chantix and off cigarettes, that I should wait until everything readjusted itself.

A few nights later, a friend invited me to a party and I reluctantly agreed. I was still avoiding my closest friends for fear that they’d notice changes in my behavior. But maybe I’d feel better if I stopped keeping to myself, for just a night. At the party, I tried to impersonate myself as best I could, but I found myself staring and nodding blankly, actually having difficulty understanding what people were trying to say, and getting oddly touchy at offhand comments.

I was offered a piece of cake on a plate and a fork. For the life of me, I couldn’t figure out the puzzle. How the hell were these pieces supposed to fit together? Fork. Plate. Cake. What sort of maniac would present me with something like this at a party? I abandoned the cake for a vodka tonic, which I drank in silent rage.

I left without saying good-bye. In the cab, I watched the city slash past the windows and was tempted to just throw open the door. Running up the stairs to my apartment, I barely had the door open before the crying started again. I sat on the edge of the bed, doubled over, and I felt severely ill, as though some freakish primal despair had finally been loosened from my stomach. The sensation was more like vomiting than any sadness I’ve ever experienced, and the shrieking sobs were punctuated by sudden jags of rage. Like a spoiled teenager, I’d suddenly uproot drawers from the bureau, push all the belongings off shelves with a sudden swat of the arm, smash a glass against the wall, and then the crying would take over yet again. Meanwhile, the room seemed to be pulsing and reverberating around me, and my eye would keep zeroing in on objects—the television, the AC, a pair of shoes—and feel as though they were somehow buzzing with life and gleefully watching me endure the biggest meltdown I’d ever had. I had somehow ruined myself, and suicide seemed like a good way to avoid the embarrassment of this fact’s being exposed.

The next morning, I called in sick to work and started cleaning up the considerable mess I’d made. I had to throw out a bunch of broken CDs, smashed glasses, torn clothes, ripped photographs, and the remaining boxes of Chantix from my medicine cabinet.

It was a good call, I think, the second most important decision I’d ever make in my life.

“Set a quit date to stop smoking,” goes the old bit of doctor’s advice. Experts argue people need to psyche themselves up, get serious, commit to quitting before the last butt goes in the ashtray.

A new study in JAMA suggests that advice may be outdated. Smokers unready to quit who took the cessation drug varenicline (Chantix) for several months, while continuing to smoke, eventually quit at much higher rates than smokers who took placebo.

Guidelines instruct physicians to counsel patients to choose an exact date of their last cigarette, before prescribing pharmaceutical aids like Chantix, bupropion, or nicotine replacement therapy. The thought was that the drugs would be wasted on people not serious about quitting — since quitting smoking is so hard. Also, some insurance companies required documentation of a quit date before authorizing payment for smoking cessation drugs.

But mounting evidence suggests this all-or-nothing psychological dynamic may be unnecessary, if not counterproductive. For most, smoking is a lifelong addiction, a behavior not easily changed. Smokers usually require multiple attempts to quit smoking, and suffer from a sense of failure after relapsing. Many smokers also cut down slowly, going on-and-off cigarettes and nicotine replacement therapy for years before finally quitting for good.

Chantix Taken for Up to 6 Months Improved Quit Rates

The study enrolled about 1,500 smokers at 60 clinics in the U.S. and internationally. The interesting requirement for enrollment of recruited smokers: not being ready to quit. Smokers only acknowledged they’d like to smoke less, and wanted to quit in the near future (within 3 months). The participants were then randomized to take either varenicline (Chantix) or placebo twice daily.

After 6 months, one-third of patients who took Chantix had quit smoking — 4 times more than those taking placebo (7%). Continuous abstinence was confirmed by exhaled carbon monoxide at follow-up visits. A similar proportion successfully quit while taking varenicline, in previous trials enrolling smokers motivated to quit.

Among those who didn’t quit, varenicline helped them cut back the number of cigarettes smoked. After 2 months, 26% of Chantix users slashed their cigarettes smoked by 3/4ths; 15% of placebo-takers achieved this.

Jon O. Ebbert, an internationally respected expert in smoking cessation from Mayo Clinic, was lead author. The study was funded by Pfizer, purveyors of varenicline, and Pfizer’s scientists contributed substantially to the trial design, statistical analysis and manuscript authorship.

It seems safe to believe Pfizer is delighted with the findings. There are about 42 million smokers in the U.S., and about 1/3 report in surveys they’d like to quit in the next 6 months. That’s a market of 14 million people; at $250 a month for Chantix, that’s a $42 billion potential yearly market. Capturing even a fraction of that would promote Chantix from second-string ($670 million annually in 2012) to superstar.

With almost 500,000 Americans dying every year from illnesses caused by smoking, Chantix starts to look like a bargain even at retail prices. The annual cost to society from smokers (medical care plus lost productivity) is estimated by CDC at $289 billion — about $7,000 per smoker — a tab we pay year after year after year.

It’s hard to understand smokers who say varenicline is too expensive, when a pack-a-day cigarette habit costs about $170, or over $2,000 a year. Using Chantix for 6 months costs about $1,250 (and less with the available coupons and payment assistance).

Chantix’s Reputation for Side Effects Limits Wider Use

But it’s Chantix’s side effect profile, not its efficacy, that have limited its wide adoption. Chantix can cause notoriously weird, vivid dreams, and is believed by many to have darker psychiatric effects. Hundreds of suicides and attempted suicides among Chantix users have been reported to the FDA since its approval in 2006.

A causal relationship has never been proven, and follow-up safety studies have not shown increased psychiatric risk with Chantix. Nevertheless, the FDA mandated and has maintained a black box warning on varenicline stating its potential for psychiatric effects, and Pfizer is reportedly paying $200-300 million to settle more than 2,500 lawsuits by Chantix users and their families.

In this study, recorded suicidal ideation or behavior was lower in the group taking Chantix (0.8%) than in the placebo group (1.3%). More patients taking Chantix had abnormal dreams (12% vs 6%), nausea (28% vs 9%) and other minor adverse events. Only about 1% more patients taking varenicline stopped taking the drug due to adverse effects, compared to placebo (8% vs 7%).

Clinical Takeaway: Quitting smoking can be lifesaving, and studies show varenicline offers smokers the best chance of quitting. On its way to blockbuster row, varenicline will have to undergo a public relations makeover and verification of its safety.

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What are the possible side effects of CHANTIX?

Terms and Conditions

By using this co-pay card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).

The value of this co-pay card is limited to $75 per use or the amount of your co-pay, whichever is less. If your out-of-pocket prescription cost is $115 or less: You will pay no more than $40 per monthly CHANTIX prescription. If your out-of-pocket prescription cost is more than $115: You will pay $40 plus the difference between your prescription cost and $115, saving up to $75 per monthly prescription. All those eligible to use the co-pay card can do so on any CHANTIX prescription—it is not limited to the first prescription. Co-pay card may not be redeemed more than 6 times within the calendar year. The maximum savings per year are $450.

Patient must have private health insurance. Offer is not valid for cash paying patients. Activation is required. Please visit www.chantixsavings.com or call 1-800-746-4678 to activate co-pay.

This co-pay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs. You must deduct the value of this co-pay card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf. You are responsible for reporting use of the co-pay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the co-pay card, as may be required. You should not use the co-pay card if your insurer or health plan prohibits use of manufacturer co-pay cards.

You must be 18 years of age or older to redeem the co-pay card.

Offer good only in the U.S. and Puerto Rico. This co-pay card is not valid where prohibited by law. Co-pay card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.

Co-pay card will be accepted only at participating pharmacies. If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. This co-pay card is not health insurance.

Co-pay card is limited to 1 per person during this offering period and is not transferable. No membership fees. No other purchase is necessary.

Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified. It will be combined with data related to other co-pay card redemptions and will not identify you.

Pfizer reserves the right to rescind, revoke, or amend this offer without notice. For reimbursement when using a mail order: Pay for the CHANTIX prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: CHANTIX Evergreen Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the co-pay card, your name, and your mailing address. Offer expires 12/31/20.

How CHANTIX works

By using this co-pay card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).

The value of this co-pay card is limited to $75 per use or the amount of your co-pay, whichever is less. If your out-of-pocket prescription cost is $115 or less: You will pay no more than $40 per monthly CHANTIX prescription. If your out-of-pocket prescription cost is more than $115: You will pay $40 plus the difference between your prescription cost and $115, saving up to $75 per monthly prescription. All those eligible to use the co-pay card can do so on any CHANTIX prescription—it is not limited to the first prescription. Co-pay card may not be redeemed more than 6 times within the calendar year. The maximum savings per year are $450.

Patient must have private health insurance. Offer is not valid for cash paying patients. Activation is required. Please visit www.chantixsavings.com or call 1-800-746-4678 to activate co-pay.

This co-pay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs. You must deduct the value of this co-pay card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf. You are responsible for reporting use of the co-pay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the co-pay card, as may be required. You should not use the co-pay card if your insurer or health plan prohibits use of manufacturer co-pay cards.

You must be 18 years of age or older to redeem the co-pay card.

Offer good only in the U.S. and Puerto Rico. This co-pay card is not valid where prohibited by law. Co-pay card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.

Co-pay card will be accepted only at participating pharmacies. If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. This co-pay card is not health insurance.

Co-pay card is limited to 1 per person during this offering period and is not transferable. No membership fees. No other purchase is necessary.

Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified. It will be combined with data related to other co-pay card redemptions and will not identify you.

Pfizer reserves the right to rescind, revoke, or amend this offer without notice. For reimbursement when using a mail order: Pay for the CHANTIX prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: CHANTIX Evergreen Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the co-pay card, your name, and your mailing address. Offer expires 12/31/20.

TUESDAY, Feb. 17, 2015 (HealthDay News) — The anti-smoking medication Chantix can boost the likelihood that cigarette smokers who aren’t ready to stop cold turkey will cut down gradually, a new study suggests.

“The main contribution of this study is that it demonstrates that for patients who are not ready to quit right away, the use of Chantix could be helpful in getting them to cut down, and then, eventually, to making a quit attempt,” said Dr. Michael Siegel, a professor of community health sciences at Boston University School of Public Health.

Still, “its success comes with a cost,” said Siegel, who wasn’t involved in the study. The medication has been linked to serious side effects, he noted.

Chantix (varenicline) is manufactured by Pfizer Inc., which funded the study. It appears to help smokers quit or cut back on their nicotine habit by making cigarette smoking less satisfying. The two-pill-a-day treatment costs about $280 a month, and patients are advised to use it for 12 to 24 weeks.

In the new study, researchers targeted a particular kind of smoker: Someone not ready to quit within the next month but willing to try to reduce smoking and quit in three months.

Study lead author Dr. Jon Ebbert, professor of medicine at the Mayo Clinic in Rochester, Minn., explained, “Some smokers prefer to reduce the number of cigarettes that they smoke before quitting smoking completely.” He said research is divided over whether this is a good idea compared to quitting completely. U.S. health guidelines recommend quitting abruptly.

In the study, researchers in 10 countries, including the United States, randomly assigned more than 1,500 smokers to take Chantix or a placebo over 24 weeks. All of the smokers were interested in cutting down but not prepared to quit cold turkey.

Researchers questioned participants and tested their exhaled carbon monoxide levels to see how much smoking they’d done. After a month, 47 percent of those who took Chantix reduced smoking by more than half or stopped altogether, compared to 31 percent of those who got the placebo. From 21-52 weeks, more than one quarter of those who took the drug had not smoked, compared to 10 percent of those who took the placebo.

Nov. 3, 2011— — Scientists say the U.S. Food and Drug Administration (FDA) should take warnings about the stop-smoking drug Chantix up a notch, citing data showing that the drug increases suicidal behavior and depression far more than other drugs and methods designed to help smokers quit.

Chantix, also called varenicline, has been hotly debated since 2007, when experts first raised questions about the long-term safety of the drug and its connection to cardiovascular problems and vision lapses. Since then, studies have reported that patients taking Chantix are at increased risk of depression and suicidal thoughts. Anecdotally, patients report wild dreams, inexplicable violent behavior and other psychological disturbances while on the drug.

In 2009, the FDA placed a “black box” warning label on Chantix and another drug, Zyban, cautioning doctors and patients about the risk of depression, hostility and suicidal thoughts.

But some researchers say these warnings don’t go far enough. Today, a study published in the journal PLoS One continued to sound the alarm against Chantix and urged the FDA to update Chantix’s warning label, saying the psychological risks of the drug exceed those of nicotine replacement drugs or even its competitor, Zyban.

Dr. Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center and one of the study’s authors, said people trying to kick their tobacco habit generally are at higher risk for psychological symptoms, but Chantix makes them far worse.

“The dramatic increase of these symptoms is caused by the drug. Among all the treatments we have for smoking cessation, Chantix is the worst,” Furberg said.

In the study, Furberg and his colleagues analyzed more than 3,000 reports of suicidal behaviors or depression in people taking Chantix, Zyban, or nicotine replacement drugs, which were reported to the FDA through its Adverse Event Reporting System from 1998 through September 2010. Of those reports, 90 percent were linked to Chantix. In reports of completed suicides of people taking these stop-smoking treatments, the study said 92 percent were associated with Chantix.

“The FDA’s own data show that Chantix is more dangerous than other treatments to stop smoking,” Furberg said.

The FDA is unmoved by this latest report. A spokeswoman for the agency said the drug is a safe and effective way to help smokers quit. Additionally, the agency noted that this latest study failed to account for an uptick in reports of psychological side effects from Chantix that occurred as media coverage of the drug increased since 2007.

Pfizer, Chantix’s manufacturer, also took issue with the data Furberg and his colleagues used in their study, saying that their reports of negative side effects are unreliable.

“Post-marketing reports can come from any source ranging from patients to healthcare providers, and from phone calls to internet postings and lawyers. Often these reports lack sufficient medical information to enable meaningful assessment,” the company said in a statement.

Pfizer also noted that at the FDA’s request, the company is conducting a clinical trial to study the link between Chantix and psychological side effects. The results are expected in 2017.

Last week, the FDA reported that two federally funded clinical trials, together studying more than 26,000 patients, showed that Chantix did not increase depression and suicidal thoughts compared with other stop-smoking treatments. However, regulators noted that these reports came only from hospitalizations, which do not always happen when patients experience depression or suicidal thoughts.

“We continue to believe that when used as directed in the currently approved labeling, Chantix is a safe and effective treatment to help patients stop smoking,” an FDA spokeswoman said in a statement.

The FDA approved Chantix in 2006, and since then, nearly 22 million prescriptions have been written and almost 9 million people got the drug from retail pharmacies. Studies showed that 33 percent of smokers who took Chantix were able to avoid tobacco six months after quitting, compared with 14 percent who took a placebo.

In 2008, the U.S. Federal Aviation Administration banned commercial pilots from using Chantix after reports surfaced that the drug was linked to black-outs and vision problems. Truck drivers have also been restricted from using Chantix.

The U.S. Veterans Administration (VA) recommends that patients take Chantix only after trying to quit smoking using nicotine replacement drugs and Zyban, and even then, the VA suggests that patients’ mental health should be evaluated before taking the drug.

Furberg and his colleagues think the FDA should adopt the VA’s approach to Chantix and should update the drug’s “black box” warning to indicate that it is riskier than Zyban and other treatments. Furberg said the benefits of stopping smoking don’t outweigh the risks of the psychological symptoms connected to Chantix.

“Smoking is bad and if we have an effective treatment for smoking cessation, I would promote it,” Furberg said. “But the benefit of this drug is so weak that you can’t tolerate the bad effects that come with it.”

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