November 3, 2011
Stop-Smoking Drug Increases Risk Of Depression Or Suicide
According to a new study, the smoking-cessation drug varenicline (Chantix) carries too many risks and should be a last-resort option for trying to quit the habit.
Researchers said that varenicline showed a substantially increased risk of reported depression or suicidal behavior compared to other smoking-cessation treatments.
The team said varenicline was eight times more likely to result in reported case of suicidal behavior or depression than other stop-smoking-aids.
"Our study contradicts the implications of a recent review by the FDA showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches," Curt D. Furberg, M.D., Ph.D., professor of Public Health Sciences at Wake Forest Baptist Medical Center, co-author of the study, said in a press release.
"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."
The scientists analyzed 3,249 case reports of serious injury included in the FDA's Adverse Event Reporting System from 1998 through September 2010 for self-injurious behavior or depression linked to varenicline, bupropion (Zyban), and nicotine replacement products.
The team found that 90 percent of those using varenicline reported suicidal behavior or depression. Just 7 percent of the case reports for bupropion were linked to suicidal behavior and depress, and 3 percent for nicotine replacement products.
"We found that Chantix is associated with more suicidal behavior reports than any other smoking-cessation drug on the U.S. market," Furberg said in a press release. "The risks simply outweigh the benefits."
He said that although other research from multiple sources establishes that varenicline increases the risk of psychiatric side effects, it remains uncertain how often these events take place.
"We strongly recommend that the FDA should 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," Furberg said in a press release.
The findings were published in the journal PLoS One on November 2.
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