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FDA Disagrees Chantix Is Potentially Dangerous Despite New Evidence

Date Posted: November 4, 2011

chantix side effectsThe FDA continues to assert that Pfizer’s Chantix, a drug used as a smoking cessation aid is a “safe and effective way to help smokers quit.” Nonetheless, a study published in the journal PLoS One on November 3, 2011 indicates that the psychological risks of the drug exceed those of other nicotine replacement drugs, including its competitor Zyban and that the drug increases suicidal behavior and depression far more than other drugs and methods designed to help smokers quit.

Chantix, also called varenicline has been the center of controversy for several years because of its reported adverse effects including changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions – according to its own label – and due to the risks of psychological events the Chantix package was required to bear the U.S Food and Drug Administration’s most restrictive safety labeling warning. In addition, patients report wild dreams, inexplicable violent behavior and other psychological disturbances while on the drug. In 2008, the Federal Aviation Administration ordered its pilots and air traffic controllers to cease taking the drug. Shortly after, Chantix was pulled from military pharmacies and the Department of Defense asked its personnel operating aircrafts and/or missile crew members to stop using the drug.

The new study led by Dr. Curt Furberg, a professor of public health sciences at Wake Forrest Baptist Medical Center said people trying to quit smoking are at a higher risk for psychological symptoms that Chantix makes them far worse.  “The dramatic increase of these symptoms is caused by the drug. Among all the treatments we have for smoking cessation, Chantix is the worst,” Furberg said.

This new study does however reveal that Chantix’s possible side effects might be more dangerous than the FDA and Pfizer, the brand that sells the drug, are actually willing to admit. “In the study, Furberg and his colleagues analyzed more than 3,000 reports of suicidal behaviors or depression in people taking Chantix, Zyban, or nicotine replacement drugs, which were reported to the FDA through its Adverse Event Reporting System from 1998 through September 2010. Of those reports, 90 percent were linked to Chantix. In reports of completed suicides of people taking these stop-smoking treatments, the study said 92 percent were associated with Chantix.”

Despite the new critical evidence, the FDA seems unfazed by the findings and claims that the drug is a safe and effective way to help smokers quit. What is even more distressing is that back in 2006, when the drug was approved by the FDA, the agency gave it a priority review, shortening the usual 10-month review period to 6 months because of its demonstrated effectiveness in clinical trials and perceived lack of safety issues. FDA drug approval can and usually takes several years. Furthermore, Pfizer has just revealed that at the FDA’s request, the company was conducting a clinical trial to study the link between Chantix and psychological effects, for which they expect to have results in 2017. Coincidentally, Pfizer’s patent on Chantix is set to expire in 2018, which means other companies will then be able to start manufacturing generic versions of the drug.

While both the FDA and Pfizer continue to claim the drug is safe, this does not seem to be the consensus amongst people who have actually used it. Yet, “we continue to believe that when used as directed in the currently approved labeling, Chantix is a safe and effective treatment to help patients stop smoking,” an FDA spokeswoman said in a statement.  Despite the FDA and Pfizer’s claims that the drug is safe, the medical community insists that more research is needed in order to assess more carefully the potential side effects of the drug and that the FDA should take additional steps to warn smokers of the increased dangers associated with its use. 

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