A team of researchers is calling on the U.S. Food & Drug Administration (FDA) to beef up warnings for <"https://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix (varenicline), after their study found the drug’s psychological side effects make it unsuitable for first-line use as a smoking-cessation aid. The FDA, however, continues to maintain that Chantix is a safe and effective way to help smokers quit.
The FDA approved Chantix in the United States in 2006 as a treatment for smoking cessation. Chantix blocks nicotine by targeting the brain’s nicotine receptors. About a year after being on the market, reports began emerging about patients exhibiting strange and dangerous behavior while on Chantix. In 2009, the FDA announced that a black box warning would be added to the Chantix label.
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 team 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 Chantix, Zyban, an antidepressant approved for smoking cessation, and nicotine replacement products. They found that since 1998, 90 percent of the cases of suicidal behavior or depression were linked to Chantix. In comparison, only 7 percent were associated with Zyban, and 3 percent were linked to nicotine replacement products.
“Our study contradicts the implications of a recent review by the FDA showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches,” study co-author Curt D. Furberg, M.D., Ph.D., said in a press release from Wake Forest Baptist. “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.”
“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.
According to Furberg, the research team concluded that Chantix should be prescribed only after failure of nicotine replacement, Zyban or a combination, a recommendation that was adopted by the U.S. Department of Veterans of Affairs (VA). The researchers also concurred with the VA’s recommendation that patients being considered for Chantix treatment undergo a mental status examination to assess risk of suicidal or violent behavior prior to prescribing the drug.
