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Harsh Side Effects Can Accompany Stop-Smoking Pill

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Harsh Side Effects Can Accompany Stop-Smoking Pill

CHICAGO (CBS) ― A pill that promises to help smokers quit is now being criticized by some people who report side effects they didn't bargain for. CBS 2 Medical Editor Mary Ann Childers reports on the no-smoking pill some call a miracle, but others say could be a dangerous cure.

Donna Rooney smoked for 25 years. She'd tried many times to quit, so she was thrilled to learn about the new smoking cessation drug Chantix. But after six weeks on the drug, Rooney had a severe vertigo attack. It left her with a balance disorder, vision problems and a tick on her left side.

"My head would twitch over to the side and my arm would life and my leg would lift," Rooney said.

She thought she'd had a stroke, until she looked at the fine print on the Chantix package insert. Nervous system, balance and visual problems are listed as rare side effects. Online, she found people who claim Chantix causes joint pain, memory problems, increased aggression, and even suicidal thoughts.

"Never in my wildest dreams did I think that was a possibility," Rooney said.

Complaints about Chantix to the Food and Drug Administration have been increasing steadily since it went on the market in August 2006. There were 48 by September, and 246 more by December. The number jumped another 602 by March 2007, and 948 more by the end of June. In all, there were 1,844 reports in 11 months.

In a smoker's brain, Chantix works by blocking nicotine receptors. That radically reduces the urge to smoke. And in many people, the effect appears to be is lasting.

"There's no physical withdrawal from nicotine while they're going through the process of quitting," said Carol Southard, RN, MSN, of Northwestern Memorial Hospital.

Southard, a nationally renowned smoking cessation expert, has 400 clients on Chantix right now.

"It's been the most successful form of therapy for smoking cessation that I have ever seen," Southard said.

Southard's clients use the drug along with an intensive stop-smoking program.

Pfizer says the most common side effects of Chantix are nausea, sleep disturbance – including changes in dreaming – constipation, gas, and vomiting. The company says Chantix has been studied in more than 5,000 patients, it is monitoring adverse event reports, and more studies are underway with people with cardiovascular and lung disease.

But the watchdog group Public Citizen says testing didn't go far enough.

"It's only when tens of thousand or more people start the drug that you get a sense of the real frequency of that effect of how serious it can be," said Public Citizen Health Research Group Director Dr. Peter Lurie.

Two months ago, Public Citizen put Chantix on its worst pill list. But former pack-a-day smoker Scott Jager swears by it.

"I don't smoke. That's the biggest thing. I don't smoke," Jager said. "All of that is Chantix, because again, I don't have any will power."

Jager says Chantix changed his life. Rooney says it changed hers, too. Ten months after stopping the drug, she's still having physical problems and needs medication. All, she says, for nothing.

"The stress of the situation ... I finally just went back to smoking," Rooney said.

Public citizen is not advocating pulling Chantix off the market, but warns that half of all big problems with new drugs surface in the first seven years. Four million people have now used Chantix.

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