Paper: Suicidal Behavior and Depression in Smoking Cessation Treatments [PLOS ONE]

[Tom09]

TJ Moore, CD Furberg, J Glenmullen, JT Maltsberger, S Singh (2011). Suicidal Behavior and Depression in Smoking Cessation Treatments. PLoS ONE 6(11): e27016
(Open Access)

Background: Two treatments for smoking cessation—varenicline and bupropion—carry Boxed Warnings from the U.S. Food and Drug Administration (FDA) about suicidal/self-injurious behavior and depression. However, some epidemiological studies report an increased risk in smoking or smoking cessation independent of treatment, and differences between drugs are unknown.
[Method: database search for varenicline, bupropion and nicotine replacement therapy products.
Results: Disproportionality of reported cases, as compared to NRT]
Conclusions: Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/selfinjurious behavior. Bupropion for smoking cessation had smaller increased risks. The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation.

Mass media article: Anti-smoking drug 'greatly raises suicide risk and should only be used as a last resort' (Dailymail, UK, 3rd November 2011)

Edit: should be noted that FDA just a week ago published a different conclusion.
(mods may move this post to the latest ECF Chantix thread here)

 

[trinifreak]

Very interesting, the US military hands chantix aka varenicline like candy (possible correlation?). I was given chantix at one point, and I did become suicidal. If it was not for vaping I would have continued taking chantix, and not say a word about my suicidal ideations, things would have been different. *smiles and takes a toot*

 

[rothenbj]

This actually made the 5 o'clock news health report in Philly this evening. I was a bit shocked that they highlighted it.

 

[Nicko]

I would like to see international headlines about that.

 

[Tom09]

I would like to see international headlines about that.

Forscher warnen vor Rauchstopp-Pille Champix, Der Spiegel (the leading news magazine in Germany)

 

[Tom09]

Reuters article , e.g. picked up by foxnews, present study author calls FDA’s recent review studies flawed

[...]
The findings contradict two studies released last month by the Food and Drug Administration that showed Chantix (sold as Champix outside the United States) did not increase the risk of being hospitalized for psychiatric problems such as depression.

The agency at the time acknowledged that those studies were flawed because they were too small to identify rare events and they only captured cases that were severe enough to land people in the hospital.

"Our study contradicts the implications of a recent review by the FDA showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches," said Dr. Curt Furberg, professor of Public Health Sciences at Wake Forest Baptist Medical Center, co-author of the study published online in the Public Library of Science journal PLoS One.

"The FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression and assaults. These can be catastrophic events but do not normally result in hospitalization," Furberg said in a statement
[...]

Edit to add:
authors press release (Wake Forest Baptist Medical Center Nov. 2, 2011)
Pfitzer’s response (PR November 3, 2011)
FDA’s pre-release damage control: Safety Announcement 10-24-2011, ECF discussion

 

[Bill Godshall]

Another article at Chantix unsuitable for first-line smoking cessation use

The American Council on Science and Health posted this about the study at Another cessation aid goes up in smoke > Facts & Fears > ACSH

November 4, 2011

Another cessation aid goes up in smoke

Two drugs used to help people stop smoking — varenicline (Chantix) and bupropion (Zyban) — carry a significantly increased risk of depression and suicidal or self-injurious behavior, according to a new study published in the Public Library of Science.

Researchers from the Institute for Safe Medication Practices in Alexandria, Virginia, analyzed adverse event reports among smokers who had been prescribed one of these drugs to help them quit. They discovered that those taking varenicline had a significantly increased risk of serious psychiatric side effects compared to patients using nicotine replacement therapy. The same was true for bupropion — an antidepressant sold as Zyban for smokers — although to a much lesser extent. Out of the more than 3,000 reported cases of suicidal/self-injurious behavior or depression analyzed in the study, 90 percent were associated with varenicline, 7 percent with bupropion, and only 3 percent with nicotine replacement. Furthermore, varenicline had a thirty-fold higher risk of such effects when compared to a control group. Considering that varenicline works by blocking the effect of nicotine on the brain, ACSH’s Dr. Ruth Kava says that the results make sense. “Many people self-medicate with nicotine for depression,” she explains. “ So blocking those nicotine receptors might thus be expected to increase a person’s depression.”

The researchers took the FDA to task for an announcement the agency had made, which downplayed the drug’s risks. Although in 2009 the FDA slapped the drug with a black-box warning about potential side effects that include mood changes or suicidal thoughts, the agency’s recent statement claimed that the data showed no particular risk of psychiatric side effects from using varenicline. Yet this statement considered only those few events of depression and suicidal or self-injurious behavior that were serious enough to land the patient in the hospital — thus excluding a large number of less severe cases and underestimating the real risks of varenicline, and, to a lesser extent, bupropion.

Based on the results, the researchers conclude that the risks associated with varenicline “render it unsuitable for first-line use in smoking cessation.” ACSH staffers agree with this conclusion, given the troubling risks associated with the use of these drugs. In light of this study, ACSH’s Dr. Elizabeth Whelan questions why public health officials continue to support the use of either drug. “Rather than promoting drugs with such a poor risk-benefit profile,” she says, “public health authorities, both governmental and nonprofit, should counsel smokers about harm reduction options like smokeless tobacco, which do not pose such a risk."