Soon after the quit-smoking pill Chantix was approved by The U.S. Food & Drug Administration (FDA) in 2006, the FDA began receiving reports of severe psychiatric disturbances in people taking it. And now, despite its known risks, University of Pennsylvania researchers plan on testing the smoking cessation medication.
Chantix, also known as varenicline, curbs the compulsion to smoke by binding to certain nicotinic receptors in the brain, blocking nicotine inhaled from cigarettes. Chantix also partly activates the receptors, stimulating release of dopamine, the “pleasure chemical.” The dopamine surge is less than with nicotine but enough to ease withdrawal and cravings.
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—the most serious warning possible—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.
Some targeted groups include those addicted to alcohol, cocaine, and methamphetamine. Reportedly, 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.
At the University of California, Los Angeles — where Chantix is being tried in meth users — physician Keith Heinzerling said, “It’s a delicate balance between the ethics of exposing volunteers and finding answers to questions we need to answer.”
Researchers are encouraged that in about a dozen studies under way or finished, patients have had no major psychiatric events.
But, according to one recent study, Chantix, being one of the most common medications to help people kick the habit, carries too many risks and should only be tried when other treatments fail, researchers have recently said. The research team urged the FDA to update the black box warning to state the study findings, that is that Chantix, varenicline, has higher risks for suicidal behavior and depression than other smoking-cessation treatments. 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.