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The FDA announced ongoing safety reviews of the drug varenicline, marketed as Chantix and designed to help smokers quit smoking. The early communication by the FDA about this ongoing safety review has to do with the possibility of increased suicidal and aggressive thoughts while taking Chantix.

FDA Release: Chantix (Varenicline)

FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.

Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

If you or a loved one has been injured as a result of using Chanitx you may be entitled to receive compensation. Medical product manufacturers are required to ensure the safety of their products before they are sold to the public. You can contact us for further advice or fill the free evaluation form.

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Latest News On Chantix

April 3, 2008 - FDA pulls video clip. WhyQuit makes video pulled clip available for viewing. Public Citizen calls upon the FDA to issue a "black box" Chantix warning, a warning reserved for drugs linked to serious or life-threatening adverse events, the strongest warning the FDA can mandate.

April 2, 2008 - WhyQuit article expresses concerns over FDA video clip not advising users of the actual number of suicides and not sharing honest efficacy and effectiveness info needed to make informed use decisions.

 

April 1, 2008 - The FDA release a new two and a half minute Chantix safety warning video clip that for the first time admits "links" to serious neuropsychiatric problems in users, including suicide.

 

May 11, 2006 - FDA Approves Novel Medication for Smoking Cessation

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Elk & Elk Media Center

FDA on Chantix: Citizen calls upon the FDA to issue a "black box" Chantix warning Medication Errors: How to avoid deadly medication mistakes? Surgical Errors: Exposing the truth Wrongful Death: Every year thousands of people die due to medical malpractice Client Testimony: An Elk & Elk Medical Malpractice Testimony: The Story of Les Hall