Study Suggests Tougher Chantix Warning Label

The smoking-cessation drug varenicline, marketed under the brand name Chantix, already carries a “black box” warning on its label. But researchers at Harvard, Johns Hopkins and other institutions, say it might not be enough.

Writing about their study in the journal PloS One, they say the drug's poor safety profile makes it unsuitable for first-line use among those who want to quit smoking.

According to the researchers, Chantix showed a substantially increased risk of reported depression or suicidal behavior compared to other smoking-cessation treatments.

'Might as well have been heroin'

“This drug might as well have been heroin,” Ken, of Kent, Wash., told ConsumerAffairs.com last year. “I suffer from constant heighten anxiety levels and frequent panic attacks. I was diagnosed with panic disorder by the doctor who prescribed this worse than crack to me.”

Teresa, a nurse from Burton, Ohio, said she took Chantix in 2008 and was able to stop smoking. However, she said she was left with a number of serious side effects that she believes will remain with her the rest of her life.

“I am so angry,” Teresa said. “I wish the drug companies would spend more time testing their product before putting it on the market to prevent, after the fact problems.”

Side effects

The researchers focused on Chantix side effects and said they found that 90 percent of all reported suicides related to smoking- cessation drugs since 1998 implicated varenicline, even though it was on the market only four years in the nearly 13-year study period. They also found that varenicline (Chantix) was eight times more likely to result in a reported case of suicidal behavior or depression than nicotine replacement products.

“Our study contradicts the implications of a recent review by the Food and Drug Administration (FDA) showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches,” said Curt D. Furberg, M.D., Ph.D., professor of Public Health Sciences at Wake Forest Baptist, co-author of the study and a nationally recognized leader in drug safety research. “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.

Too risky

Furberg said he and his colleagues concluded that when it comes to Chantix, “the risks simply outweigh the benefits.”

The researchers said they strongly recommend that the FDA revise the black box warning to say what this study and the FDA’s own data show – that varenicline has higher risks for suicidal behavior and depression than other smoking-cessation treatments.