Study: No suicide risk for anti-smoking medications Chantix or Zyban

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There has long been a lot of controversy swirling about Chantix because of concerns that it raises people’s risk of suicide. I had not heard the same thing about Zyban, but apparently there have been concerns about this drug, too.

The concerns were serious enough that warnings were required on boxes of Chantix and Zyban that in some people, they increased the risk of mood problems, which included the risk of suicide. It’s a big enough deal that airline pilots and air traffic controllers are actually forbidden from using Chantix or Zyban. It’s also a big enough deal that many doctors will not prescribe Chantix or Zyban for people trying to quit cigarettes.

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However, a major study involving more than 8,000 patients in 16 countries showed no increase risk of suicide.

From SFGate:

The 8,144-patient, 16-country study divided participants into four groups, each receiving either Chantix, Zyban, a nicotine replacement patch or dummy pills. They got treatment for 12 weeks and then were followed for another 12.

Half the participants had existing psychiatric problems — depression, anxiety, post-traumatic stress, obsessive-compulsive disorder or schizophrenia. Those conditions are more common in smokers than nonsmokers and make it harder to quit.

Among participants without psychiatric problems, the risk of suicidal thoughts or behavior or other serious mental health issues was very low and statistically the same: about 1.3 percent for those taking Chantix, 2.2 percent with Zyban, 2.5 percent with the nicotine patch and 2.4 percent with a dummy pill. In the half with psychiatric problems, those risks were higher across the board: about 6.5 percent for Chantix and Zyban and 5 percent for the nicotine patch and dummy pill.

No participants committed suicide, though two taking dummy pills and one taking Zyban attempted it. The drugs can cause other side effects: mostly nausea, insomnia, abnormal dreams and headaches.

Chantix and Zyban “pose no greater risk for suicide or suicidal ideation than the patch or nothing,” concluded Dr. Norman Edelman, a pulmonary specialist and the American Lung Association‘s senior science consultant.

In response to this study, the manufacturers of Chantix and Zyban — Pfizer and GlaxoKlineSmith — are asking the Food and Drug Administration to remove the suicide warnings from their products. I also found online a veritable cottage industry of law firms willing to represent people wanting to sue drug companies over Chantix and Zyban over the reported side effects. I could see this getting messy.

From the article:

“We believe the available scientific information doesn’t support a boxed warning,” Dr. Freda C. Lewis-Hall, a psychiatrist and Pfizer’s chief medical officer, told The Associated Press in an exclusive interview.

Pfizer executives and longtime medicinal chemist Jotham Coe, the inventor of Chantix, think it’s been vindicated. Coe, who still works at Pfizer, is a former smoker who quit cold turkey after his father, uncle, aunt and both grandmothers died of cancer or emphysema after years of smoking.

“I understand how difficult and grueling the quitting journey can be,” he wrote.

New York-based Pfizer Inc. hopes to discuss the results with regulators around the world, including the FDA, which isn’t saying what it will do.

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