Despite its known risks, University of Pennsylvania researchers plan on testing the smoking cessation medication, Chantix (varenicline). The U.S. Food & Drug Administration (FDA) approved Chantix in 2006.
Chantix blocks nicotine by targeting the brain’s nicotine receptors; however, 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—it’s most serious—would be added to the Chantix label.
Experts reviewing the FDA’s Adverse Event Reporting System (AERS) discovered that Chantix was implicated in more violent situations than any other prescription medication said Philly.com. Chantix was also linked to more suicide, self-injury, and depression cases than other smoking-cessation treatments.
Despite the drug’s links to serious adverse events, University of Pennsylvania researchers, as well as other medical centers, have initiated Chantix testing in people who might be at higher risk for some of the psychiatric side effects that many experts find troubling, said Philly.com. Some targeted groups include those addicted to alcohol, cocaine, and methamphetamine. Of note, said Philly.com, no medication has ever been approved to treat cocaine or methamphetamine addictions, although they have been long researched.
Some experts believe that Chantix is generally considered safe and the research is called for, said Philly.com, noting that some smoking addictions can lead to significant health devastation that some feel outweighs any of the drug’s risks. But, researchers conducting the pilot Chantix trials, which are, for the most part, federally funded, agree that Chantix use in high-risk patients is medically and ethically questionable, Philly.com reported. “It’s a delicate balance between the ethics of exposing volunteers and finding answers to questions we need to answer,” said physician Keith Heinzerling of the University of California, where Chantix is tested in methamphetamine users, said Philly.com.
We recently wrote that another research team urged the FDA to beef up warnings for Chantix after their study found the drug’s psychological side effects made 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.
That study was conducted by a team from Wake Forest Baptist Medical Center, the Institute for Safe Medication Practices, Harvard Medical School, and Johns Hopkins University School of Medicine and involved 3,249 case reports of serious injury from the FDA’s AERS 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. The team found that, since 1998, 90% of the cases of suicidal behavior or depression were linked to Chantix.
“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 recent press release from Wake Forest Baptist. “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 concluded.