November 3, 2011

Smoking Cessation Drug has Side Effects

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Joseph V. Madia, MD By:

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Varenicline use linked to suicidal behavior

(dailyRx News) Quitting smoking is a healthy lifestyle choice, and many people turn to pharmaceuticals for help. But for one drug, scientists have found that the risks may outweigh the benefits.

A new study has found that the drug varenicline, branded as Chantix, is unsuitable for smokers who have just started trying to quit and should only be prescribed after other pharmaceutical treatments have failed. Varenicline showed a substantially increased risk of suicidal behavior or depression compared to other smoking-cessation treatments.

"Talk to your doctor about Chantix's side effects."

Chantix is a non-nicotine prescription medication, produced by Pfizer. It targets nicotine receptors in the brain, and blocks nicotine from reaching them. According to its website, over 7 million people have already been prescribed Chantix.

Researchers found that varenicline was implicated in 90 percent of all reported suicides related to smoking-cessation drugs since 1998, even though the product was only on the market for four years of the study period. Additionally, varenicline was eight times more likely to result in a reported case of suicidal behavior or depression than nicotine replacement products.

The new study contradicts a recent FDA study, which showed no difference in hospitalizations caused by varenicline and nicotine replacement patches. Dr. Curt Furberg, one of the study authors, said the FDA study was flawed because it didn't capture the serious psychological side effects, like suicide, which would not result in hospital visits.

The risks simply outweigh the benefits, Dr. Furberg said. Out of 3,249 case reports of serious injury from FDA data linked to various smoking-cessation treatments, 2,925 (90 percent) cases of suicidal behavior or depression were linked to varenicline.

Chantix already contains a “black box warning,” required by the FDA, to warn consumers of the psychological side effects. The study authors advise that the FDA revise the warning, to state that it has higher risks for suicidal and depressive behaviors than other drugs in its category. They also recommend that if varencicline is prescribed, it should only be done after other drug treatments fail.

The study was published in the journal PloS One, in November 2011.

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Reviewed by: 
Joseph V. Madia, MD
Review Date: 
November 2, 2011

Last Updated:
November 14, 2011