CHANTIX UNDER REVIEW!!!!!!!

[RandyW]

Stop-smoking drug Chantix under review

Thursday, December 6, 2007

By Sam Blackwell ~ Southeast Missourian

Jill Gibson and Billy Abernathy of Morley, Mo., both recently stopped smoking while using the prescription drug Chantix. Neither Gibson nor Abernathy had heard about the FDA's new review of the drug but had already stopped taking it.

(Fred Lynch)

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When approved by the Food and Drug Administration in 2006, the prescription drug Chantix was heralded as almost a silver bullet in the fight to help people stop smoking. Its ingredient, varenicline, blocks nicotine receptors to the brain while stimulating a dopamine response.

After six clinical trials, Chantix was fast-tracked to the market because of its potential to benefit the public's health. But last month reports of suicidal thinking and behavior and aggressive and erratic behavior led the FDA to begin a review of Chantix. At its Web site the FDA is asking the public to submit information about their experiences with the drug.

The agency has recommended that physicians monitor patients taking Chantix for changes in mood and behavior. The FDA also is concerned about reports that patients have become drowsy, a danger when driving or operating machinery.

Chantix has been used successfully in new smoking cessation programs at both Saint Francis Medical Center and Southeast Missouri Hospital in Cape Girardeau. Four Saint Francis employees were the first graduating class at that hospital.

Terry Baker, who runs the program at Saint Francis, said questions about Chantix have not come up. She said any prescription drugs used by people in the program are prescribed by their own physician. "If somebody is going through the program, their family doctor knows more about them," she said.

Chantix pills

(Kit Doyle)

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Cindy Seyer manages a similar program at Southeast Missouri Hospital through the hospital's Wellness Center. Six employees at Havco Wood Products quit smoking from a starting class of 45. All six who succeeded used Chantix. Seyer said two had negative reactions. One, a diabetic, encountered problems with blood sugar regulation. "The other expressed the feeling of being 7 feet tall," she said.

In one Chantix case the FDA is looking at, a well-known Dallas musician beat up his girlfriend and was shot to death by a neighbor while trying to kick down the neighbor's door. He had begun taking Chantix a week before. People who knew the musician say the behavior was unlike him.

The FDA subsequently released to a Dallas TV station a list of more than 5,000 complaints about Chantix filed immediately after the agency announced it was looking at possible mood changes.

Pfizer, the company that makes the drug, claims that 44 percent of people who begin taking Chantix are not smoking after 12 weeks. The side effects include nausea, depression, anxiety, heart palpitations and vivid dreams. Its response to the FDA review pointed out that quitting smoking "is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illnesses."

Jill Gibson and boyfriend Billy Abernathy, both of Morley, Mo., recently stopped smoking by using Chantix. Gibson, 51, had smoked since she was in junior high school. Both her parents and three siblings smoked. Thirteen years ago she quit cold turkey for a year and a half, then started again when she went through a divorce and started bartending.

This time she decided to quit because her doctor told her she would be walking around with oxygen tanks within 10 years if she didn't. Abernathy, also a longtime smoker, quit to show support for Gibson and because he has high blood pressure.

She started taking Chantix on Oct. 29. The school bus driver stopped taking it last week because she developed flu-like symptoms and was afraid the Chantix would interfere with the antibiotics she began taking.

She said she has had only one or two cigarettes since quitting.

'Weird dreams'

The only side effect she reports is "weird dreams, far-fetched, almost on the verge of hallucinating."

Abernathy was a two-pack-a-day smoker who doesn't carry Marlboros in his pocket anymore but admitted "I still want to eat one now and then."

The disabled former welder takes medication for high blood pressure and an antidepressant. The side effect he noticed while taking Chantix was that his blood pressure shot up. His doctor told him to double the amount of blood pressure medicine he takes.

Neither Gibson nor Abernathy had heard about the FDA's new review but had already stopped taking Chantix.

Chronic obstructive pulmonary disease, lung cancer, coronary artery disease, high blood pressure and cancer are a few of the medical problems attributable to smoking. Dr. Brad Bittle, a Cape Girardeau pulmonologist, prescribes Chantix for his patients who want to quit. "I think it's a very excellent drug," he said. He has seen it succeed even for patients who are hard-core smokers.

Some patients cannot tolerate the drug, Bittle said. Nausea is the primary complaint he hears.

He doesn't prefer Chantix to any of the other methods available to help smokers stop. "If working on smoking cessation with a patient, you try to individualize that," he said, but added, "It does in some patients work much better than treatments in the past."

Drugs or patches can't deal with the habituation part of smoking, Bittle said. He notes that the Chantix prescription contains a contact number for patient support.

Smoking isn't just a concern for medical doctors. Dental hygienist Joan M. Davis is in charge of smoking cessation at the SIU Dental Hygiene Program in Carbondale, Ill. Smoking reduces the body's ability to fight infection -- gum disease is a bacterial infection -- and hinders the immune system's ability to protect the body, she said. It also causes bone and tooth loss. Ninety percent of oral cancers are caused by smoking.

Davis is a certified tobacco treatment specialist through the Mayo Clinic in Rochester, Minn. She said the FDA review "gives me pause in the sense of making sure they understand there have been reports of depression. But in my dialogue with different professionals it is not the actual medication. It's the sudden withdrawal of nicotine that can lead to depressive episodes."

She compares smoking while taking Chantix to "smoking a carrot. They get no reward from it."

Killed the cravings

Patients are supposed to take Chantix for three months in ever increasing dosages. Havco Wood Products employee Billy Mercer stopped taking the pills three weeks into the program when he began having heart palpitations and acid reflux. Those symptoms disappeared hours later, he said. And he did not start smoking again.

"As far as killing the cravings go, it was absolutely unbelievable," he said.

Mercer's wife, Patti, also took Chantix to quit smoking. She stopped taking it after two weeks when she broke out in hives. Then she went cold turkey and hasn't smoked since Nov. 3.

A former 2 1/2-pack-per-day smoker now in his mid-30s, Mercer said he had quit at least three times previously since age 17. "I was trying to stop because people wanted me to stop," he said.

But in the past year he noticed a difference in how he breathed. Then his aunt, a smoker, was diagnosed with lung cancer. "That was a wake-up call," he said. "I was dead serious that I was going to quit smoking."

The counseling in the smoking cessation program is key, Mercer said. Each participant writes down their reasons for quitting and identifies whether they're a stress smoker or a habit smoker.

Mercer was a habit smoker. "I smoked because that's what I did. There were times I would smoke more than other times: when I was on the computer, watching TV or driving my car."

The 10-minute approach

The counselors told the participants to delay smoking by 10 minutes whenever those habits triggered an urge to light up. "You realize, I'm not going to die if I don't have a cigarette," he said.

Mercer chewed on straws to replace the habit of doing something with his fingers.

Despite his adverse reaction to Chantix, he believes in its ability to help people stop smoking. "Chantix totally makes you forget about cigarettes," he said.

Jill Braswell, the human resources manager at Havco, arranged the company's participation in the Southeast Missouri Hospital Program, making it available to anyone. Though a smoker herself, she did not join in.

Braswell began smoking again earlier this year after 10 years of being smoke-free. "I took up golf real serious this year," she explained. "It's making me a madwoman because I'm so competitive."

She said she'll quit smoking when she begins treating golf more like the game it is.

sblackwell@semissourian.com

335-6611, extension 137

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