FDA Downplays Chantix Risks, New Study Finds Chantix is Dangerous
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Last week, the Food & Drug Administration (FDA) released the findings of two federally-funded studies and found that anti-smoking drug Chantix did not increase psychiatric problems in patients taking the drug.
The studies relied upon by the FDA followed more than 26,000 patients taking Chantix.
Volatile History
Chantix, which is manufactured by major pharmaceutical company Pfizer, was first approved for use in 2006. Beginning in 2007, experts began raising safety concerns about Chantix, citing cases of cardiovascular problems and changes in vision.
As more people began to take Chantix, more reports of depression and suicidal thoughts were reported by patients taking the drug. This prompted the FDA to place a black box warning label on Chantix in 2009 to caution doctors and patients about the drug’s risk of causing depression, suicidal thoughts, and hostility.
FDA’s Studies Miss the Mark
The two studies cited by the FDA did not produce definitive findings. The studies, conducted by the Department of Veterans Affairs and the Department of Defense, were not large enough to determine rare side effects. Additionally, the studies reported psychiatric problems that led to hospitalizations only, which completely disregarded any unreported issues.
New Study Urges FDA to Update Chantix Warning Label
A study published in PLoS One Journal found that Chantix makes psychological symptoms far worse than any other nicotine replacement drug. Although this study was much smaller than the federally-funded studies, it focused specifically on adverse event reports of depression and suicidal behaviors in people taking Chantix, its competitor Zyban, or other nicotine replacement drugs. The adverse events were reported through the FDA’s Adverse Event Reporting System (AERS).
The findings of the study are alarming. A staggering 90 percent of the 3,000 reports of suicidal thoughts and depression were linked back to Chantix. Of those completed suicides, 92 percent were linked to Chantix.
Despite these findings, the FDA continues to report that Chantix is a safe and effective way for smokers to kick the habit. Pfizer released a statement regarding this most recent study, saying “often these reports lack sufficient medical information to enable meaningful assessment.”
Know Your Risk
Nearly 22 million prescriptions have been written for Chantix since it was first approved in 2006. Since then, commercial pilots have been banned and truck drivers have been restricted from taking the drug, due to black-outs and vision problems.
The Veterans Administration recommends its patients undergo a mental health evaluation before being prescribed Chantix. Experts behind the most recent study agree, saying that the risks associated with Chantix outweigh the benefits.
