FDA Needs To Boost Warning For Chantix A new study has found that Chantix has been named in more suicidal behavior and depression reports to the U.S. Food and Drug Administration (FDA) than any other stop-smoking remedy. While Chantix has been named in 90 percent of such reports since 1998, Zyban, an antidepressant used to help people quit, accounted for only 7 percent of suicide and depression report, while nicotine replacement products were named in only 3 percent.
This new study, which appears in the Nov. 2 edition of the journal PLoS ONE, was conducted by a team of researchers from Wake Forest Baptist Medical Center, the Institute for Safe Medication Practices, Harvard Medical School and Johns Hopkins University School of Medicine.
The FDA hospitalization studies were flawed
“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 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.”
The study team is calling on the FDA to boost the already-existing black box warning for Chantix and psychiatric side effects.