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Smoking-cessation drug deserves a chance despite reports of adverse side effects

About six weeks ago, the U.S. Food and Drug Administration released a statement about an ongoing safety review of Chantix, the novel smoking-cessation drug approved in May 2006.

About six weeks ago, the U.S. Food and Drug Administration released a statement about an ongoing safety review of Chantix, the novel smoking-cessation drug approved in May 2006.

The communication focused on reports of depressed moods, suicidal thoughts, and changes in emotion and behavior within days to weeks of starting Chantix. It also noted a “highly-publicized case of erratic behavior leading to the death of a patient using Chantix.”

It didn’t take long to discover that the highly publicized case involved Carter Albrecht, a Dallas musician best known as the keyboardist for Edie Brickell and the New Bohemians. An ABC News report titled “Girlfriend Believes Chantix Contributed to Texas Musician’s Death”) and others gave the following details:

A week after starting Chantix, Albrecht and his girlfriend returned home after having a few drinks at a local bar. When Albrecht became progressively more agitated, confused and uncharacteristically aggressive, his girlfriend locked him out of the house. He ended up banging deliriously at the back door of his neighbor, Will “Smokey” Logg. Startled from sleep and worried for his safety, Logg warned Albrecht that he had a gun then fired a self-described “warning shot” that traversed the upper portion of the door and critical portions of Albrecht’s brain. Albrecht died at the scene.

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Groping for answers to this incomprehensible tragedy, Albrecht’s grieving girlfriend and a community of musician friends were quick to blame Chantix. They didn’t blame alcohol (Albrecht’s blood-alcohol level was 0.29) or the gun laws in Texas, which remove any obligation for a crime victim to retreat before responding with deadly force. Logg will not face any charges.

Alcohol and drugs are never a good mix
In either case, the side effects of Chantix and the right to bear arms should not be taken lightly. Pfizer, the manufacturer of the non-nicotine prescription drug, makes no specific claims about mixing Chantix and alcohol. But as a rule, no drug manufacturer recommends mixing booze and drugs, particularly when the drug works through the brain. The strange nightmares Albrecht was having the week before his death are a known side effect of Chantix; sleep deprivation may have made his brain more sensitive to the effects of alcohol and perhaps fueled his psychotic break.

As the FDA safety review points out, there’s a complex relationship between smoking, smoking cessation and mental health. First, smoking is much more common in those with mental health problems. Although 21 percent of Americans smoke, people with psychiatric conditions are twice as likely to smoke as the general population, and they smoke more heavily. Second, everyone who goes through nicotine withdrawal may experience symptoms of depression and a worsening of their illness.

What will come of these case reports on Chantix is unclear. As with all new drugs, some side effects that are not apparent in the initial studies required by the FDA might come to light as the drug hits the market and tens of thousands of patients begin taking it.

FDA-approval studies for Chantix involved 4,500 patients. According to Dr. Marc Manley, head of tobacco-cessation programs at BlueCross BlueShield of Minnesota, 46,000 of the insurer’s members used Chantix in just the first three quarters of 2007. The experience has been good.

“We’re aware of the FDA safety notice, but the numbers are very, very small at this point, and we haven’t seen anything in our users to suggest there’s a problem,” Manley noted. “Every time a new drug comes out for smoking withdrawal, there is always some stir about potential problems. I remember when the nicotine patches came out, there were articles coming out saying that they were causing heart attacks because people were overdosing on them, which was hard to believe because historically nicotine patches are markedly under-dosed.” The concern proved to be unfounded.

Since smoking kills more people prematurely than any other cause, including the neighbor’s handgun, Chantix could be a lifesaving medication and we should give it time. We may even need to work with a more serious side-effect profile from Chantix because nicotine addiction is a serious disease. Still, we shouldn’t let a high-profile case like Carter Albrecht’s prematurely snuff out a promising smoking-cessation drug. Too much is at risk.

Need help?
Free smoking-cessation coaching service for BlueCross BlueShield of Minnesota’s members is available at 1-888-662-BLUE (2583).

ClearWay Minnesota’s quit-line service for uninsured or underinsured Minnesotans is 1-888-354-PLAN (7526) or online.